It was reported to aesculap inc.That a prestige atra grasper dbl-act 5mm (part # 8360-10) was used during a laparoscopic cholecystectomy procedure performed on (b)(6) 2022.According to the complainant, during the procedure, during the procedure, a jaw breakage occurred.The patient received an x-ray as a result of this event.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.The malfunction is filed under aag reference xc 100031470; cc 400568532.
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Manufacturer evaluation: the device was returned to the manufacturer for physical evaluation.A visual examination of the device was performed which revealed that a disassembly of the distal jaw occurred, which caused the jaw to separate from the housing.However, both links were present at tip, and only a single grasper jaw separated.Additionally, the handle function was not smooth, and actuation of the grasper felt resistive and inconsistent.An investigation of the device manufacturing records was not able to be performed as the serial # of the device in question was not available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.The investigation into the cause of the reported problem was able to confirm the failure mode of distal jaw separation.In addition to a supplier corrective action request (scar) being initiated, a corrective action/preventive action (capa) was opened by aesculap inc.For further evaluation of the design transfer of this device.
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