(b)(4).The contact¿s phone number was not provided.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 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 determined that the swing head was torn.It was further determined that the device failed for check saw blade coupling, functional test, check trigger and ecu (electric control unit) function, check oscillation frequency.Min 10800-14200 osc/min, mode switch-test and for check performance.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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