Udi: gtin is unavailable as the product made prior to compliance date; (b)(4).Initial reporter¿s phone number: (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 during service and evaluation, it was discovered that there was oil leak on the foot control device.It was further determined that the device had oil loss, the winkle adapter was loose and defective and the hose was worn out.It was further determined that the device failed for drip rate assessment.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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