Additional narrative: (b)(4).(b)(6).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 attachment device had an undetermined malfunction.During the pre-repair diagnostics assessment, it was determined that the device had damaged component to the bearings.It was further determined that the crani strap was worn out and the extension sleeve was slightly damaged.It was further observed that the heavily woven pins had moved (migrated) and the symbol was missing.It was further determined that the device failed for visual assessment and for vibration.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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