Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
Intuitive Surgical
240 recalls • • Categories: Other Medical Devices, Surgical Instruments, Infusion Pumps, Diagnostic Equipment
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Class I - Dangerous
There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.
Class I - Dangerous
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
Class I - Dangerous
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
Class I - Dangerous
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
Class I - Dangerous
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.
Potential staple deployment failure and device fragment generation
Class I - Dangerous
Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery
Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.
Class I - Dangerous
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Class I - Dangerous
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Class I - Dangerous
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Class I - Dangerous
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Class I - Dangerous
As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitives existing risk documentation.
Class I - Dangerous
Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain.
Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.
Incorrect expiration date on its package labeling (shipper box and inner carton label).
Class I - Dangerous
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.
Class I - Dangerous
One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.
Class I - Dangerous
One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.
Class I - Dangerous
Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.
Class I - Dangerous
Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.
Class I - Dangerous
Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.
Class I - Dangerous
Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.
Class I - Dangerous
Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
Class I - Dangerous
Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.
Class I - Dangerous
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.
Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.
Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.
The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.
The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.
Class I - Dangerous
The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.
Class I - Dangerous
This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which prohibits the activation of monopolar energy from the surgeon console.
The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.
Class I - Dangerous
The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.
Class I - Dangerous
During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility.
Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.
Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.
Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.
Class I - Dangerous
An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.
Class I - Dangerous
Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.
Class I - Dangerous
Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.
Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (ACJ) boards that were found to have a high rate of failure due to a defective component.
Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument.
da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion of a system arm.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.