Device was used for treatment, not diagnosis.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that 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 will be submitted accordingly.
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It was reported from (b)(6) that during service and evaluation, it was determined that the control unit of the small battery drive device was not functioning and was defective.It was noted that the handpiece had no response, the motor was jammed, and the electronic control unit (ecu) magnetic plate fell off.It was further determined that the device failed pretest for check the triggers and ecu function, check switching function, check the oscillation angle, and check the off/oscillation/on switch mode function.It was noted in the service order that the device was not working.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 the event was not reported, however, it was reported that the event occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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