Class I - Dangerous
The devices were shipped unsterilized.
Ethicon Endo Surgery
Class I - Dangerous
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
Class I - Dangerous
Identified curing issues with the silicone during the needles manufacturing process.
Class I - Dangerous
Identified curing issues with the silicone during the needles manufacturing process.
Class I - Dangerous
Identified curing issues with the silicone during the needles manufacturing process.
Class I - Dangerous
Identified curing issues with the silicone during the needles manufacturing process.
There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
Class I - Dangerous
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
Class I - Dangerous
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
Mislabeled: Labeled on the package as 60mm contains 45mm devices
Class I - Dangerous
A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.
Class I - Dangerous
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Class I - Dangerous
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Class I - Dangerous
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Class I - Dangerous
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Class I - Dangerous
Observed reported incidence rate for harm associated with intraoperative bleeding
Class I - Dangerous
Observed reported incidence rate for harm associated with intraoperative bleeding
Class I - Dangerous
Observed reported incidence rate for harm associated with intraoperative bleeding
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired
Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.
Class I - Dangerous
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Class I - Dangerous
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Class I - Dangerous
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Class I - Dangerous
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Class I - Dangerous
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
Class I - Dangerous
There is a potential for the devices to create staples that do not meet formed staple height specifications which can result in malformed staples.
Class I - Dangerous
There is a risk that the pinion gear in the device could fail under extreme use cases.
Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.
Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.
Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit.
During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.
The device may have a non-conforming component that may cause the device to fire an unformed staple.
Class I - Dangerous
During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
Class I - Dangerous
During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIPÂż 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device.
Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIPÂż 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIPÂż 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence.
Class I - Dangerous
Damage to the packaging may have compromised the sterility of the device.
Potential for self activation while the device is in use, which may result in unintended thermal damage.
Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATEÂż PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH01 and PPH03) and TranstarÂż Circular Stapler Procedure Set (STR10) due to difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation.