Gtin is unavailable as the product made prior to compliance date; (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 not determined.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 during service and evaluation, it was discovered that the foot control device had damaged component to the hole/cut in the hose.It was further determined that the hose was torn, the ce-number did not exist and the locking was defective.It was further observed that the device had oil loss and was giving away air.It was noted on the service order that the hose was torn.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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