(b)(4).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to premature wear from normal use and servicing.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 the battery oscillator device had an undetermined malfunction.During the pre-repair diagnostics assessment, it was determined that the control unit was not functioning and was defective.It was further observed that the blade holder was torn and the controller was defective.It was further determined that the device failed for check trigger and ecu (electric control unit) function, check saw blade coupling and for functional test.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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