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Model Number 8360-10 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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If additional information or investigation results become available, a supplemental report will be submitted.
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Event Description
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It was reported that there was an issue with a prestige grasper.During a laparoscopic gynecological procedure, the device would not open after placement through the trocar into the abdomen.The grasper was removed from the patient and handed to the surgical technician.The technician proceeded to attempt to use the handle to open and close the device.Next, the end of the jaw (lower piece) fell off onto the mayo stand.The surgeon requested a different grasper and completed the case successfully.
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Manufacturer Narrative
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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 both jaws were returned disassembled.Additionally, the handle function was not smooth and consistent, and jaw misalignment was observed.An investigation of the device manufacturing records was conducted by the manufacturer for the lot # of the device in question.No non-conformances were reported.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.Additionally, historical scrap rates were reviewed with no increase observed in scrap related to the complaint issue.The investigation into the cause of the reported problem was able to confirm the failure mode of jaw failure.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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Search Alerts/Recalls
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