Additional narrative: (b)(4).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 device wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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It was reported on the service order by (b)(6) that the motor device had a lever lock defect, was noisy and heating.During service and evaluation, it was observed that the motor device had a damaged component - drive shaft bent, coupling and controller defective, coupling sleeve blocked, coupling does not lock.It was further determined that the device failed pre-test for safety and cutter lock.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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