Gtin is unavailable as the product was made prior to compliance date; (b)(4).(b)(6).The 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.However the assignable root cause could not be determined.If additional information should become available, a supplemental medwatch report will be sent accordingly.
|
It was reported by (b)(6) that during service and evaluation, it was observed that the outer hose on the motor device came apart.It was further determined that the tube was worn, lid was missing, coupling was worn and machine got hot.It was further determined that the device failed pre-test for motor thermistor assessment, handpiece temperature assessment, hand control, safety and air pump.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.
|