Gtin is unavailable as the product made prior to compliance date; (b)(4).(b)(6).The 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 excessive 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 bearings was damaged on the attachment device.During the pre-repair diagnostics assessment, it was determined that there was damaged component to the bearings/corrosion.It was further observed that the ball bearings were damaged and the outer tube was badly worn.It was determined that the device failed for visual assessment (outer tube worn), vibration (heavily), and for temperature.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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