(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.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 from (b)(6) that the small battery drive device equipment became inoperative, not contacting battery case.During service and evaluation, it was noted that the device motor seized, jammed, and was heavy moving.It was noted that the motor had low power.It was also noted that the device failed pre-repair diagnostic tests for off/osc/on switch mode function, oscillation angle, triggers and electronic control unit (ecu) function, switching function, and power at the motor with test bench.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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