(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.The assignable root cause was determined to be due to wear from normal use and servicing over time.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 motor device unlock node did not work and handpiece was hot on the motor device.During service and evaluation, it was observed that the locking mechanism was not functioning, and the hose and coupling were worn.It was also noted that the device failed pre-repair diagnostic tests for safety assessment.It was not reported if the device was used in 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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