Udi: (b)(4).Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be traced to user, which is user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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It was reported by (b)(6) that during service and evaluation, it was determined that the moving parts of the trigger did not move smoothly on the battery reamer/ drill device.It was determined that the device had corrosion/ rusting/ pitting, cosmetic damage, a worn coupling, and the motor was damaged and would not run.It was further observed that the device had insufficient/ low power, a worn housing and excessive noise.It was further determined that the device failed pretest for trigger test, check power with test stand, minimum 190 to 250 watt and check the triggers and ecu (electronic control unit).It was noted in the service order that the device was not working properly during pre-surgery.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2019.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
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