Surgical Instruments

Device and tray that houses the device did not pass steam sterilization process validation testing

There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog number listed in the table above. BD has been informed by our supplier that the external threads on some of the collets (Figure 1) contain a machining burr, potentially causing the collet to not fully seat in the knife handle (Figure 2), inhibiting complete grip of the inserted knife blade possibly resulting in a loose blade.

Device and tray that houses the device did not pass steam sterilization process validation testing

Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)]

The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as another device must be used or suboptimal thrombus removal if the problem is not detected.

Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.

The surgical gowns were manufactured in a facility that is not registered by the FDA.

The surgical gowns were manufactured in a facility that is not registered by the FDA.

The surgical gowns were manufactured in a facility that is not registered by the FDA.

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.

The surgical gowns were manufactured in a facility that is not registered by the FDA.

In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.

The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

The surgical gowns were manufactured in a facility that is not registered by the FDA.

The surgical gowns were manufactured in a facility that is not registered by the FDA.

The surgical gowns were manufactured in a facility that is not registered by the FDA.