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.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.An evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was traced to improper maintenance.Udi: (b)(4).
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It was reported from netherlands that during service and repair/pre-testing, it was observed that the battery handpiece device moving parts did not move smoothly, the trigger was sticky, failed leak tightness, the mechanics had seized, the etching was illegible, had component damage and the housing was worn.The device also failed pretests for marking and labeling, leakage test using bubble emission technique, check for mechanical free moving, check for sticky triggers and check wear on housing.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2021.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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