Model Number 8360-10 |
Device Problem
Break (1069)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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Additional information / investigation results will be provided in a supplemental report, if available.
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Event Description
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It was reported that there was an intraoperative issue with a prestige grasper.The device broke during a laparoscopic cholecystectomy procedure.The distal end of the grasper fell apart during the surgery.There was a 15-20 minute delay; this was the time required to remove the fragments and acquire another device.The surgery was successfully completed with the back-up device with no known harm to the patient.Additional information was not provided.
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Manufacturer Narrative
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Manufacturer evaluation: the complaint device was returned to the manufacturer for physical evaluation.A visual examination revealed that the device showed signs of repair (proximal weld and metal finish).The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.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.A definitive conclusion regarding the complaint incident was not able to determined due to the condition of the returned device.Therefore, the investigation was not able to confirm a device or production problem that would have resulted in the reported event.
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Search Alerts/Recalls
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