Udi: (b)(4).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to normal wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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It was reported from (b)(6) that during service and evaluation, it was determined that the craniotome device neuro tip and bearings were damaged, the identification was unreadable, the ball bearing disassembled, balls were missing and the cage was not available.It was also observed that the craniotome handle was damaged (bent and abrasion), the triangle symbol was missing and the hanger, clamping and bearing failed.It was further determined that the device failed pretest for temperature, cutter insertion, lock operation and visual assessment.It was noted in the service order that the device had an unspecified malfunction.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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