(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.(b)(4) evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to device wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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It was reported by (b)(6) that during service and evaluation, it was observed that the housing was broken and torn off, and the trigger/slider was broken, blocked and jammed on the battery handpiece device.It was noted in the service order that the device had a hard trigger and deteriorated from age.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 this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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