If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 traced to environment.Udi: (b)(4).
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It was reported from the (b)(6) that during service and evaluation, it was determined that the battery oscillator device would run in an unexpected direction/mode, the device had a foreign substance/cleaning/sterilization, the device was making unexpected noise, and had unintended activation/motion.It was further determined that the device failed pretest for check function of device, check for unintended motion, and check oscillation frequency with frequency meter.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 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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