Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The 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 maintenance deficiency.Udi: (b)(4).
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It was reported from (b)(6) that during service and evaluation, it was determined that the battery handpiece device moving parts did not move smoothly - trigger and additional parts did, cracked/damaged housing, component damage and sticky trigger.It was further determined that the device failed pretest for check fitting of the lids, check roundness of the housing, check for sticky triggers, check for mechanical free moving and leakage test using bubble emission technique.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 unknown.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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