It was reported from (b)(6) that during service and repair/pre-testing, it was observed that the battery oscillator device had mode switch stuck, sticky trigger, component damage, contact damage, high output/power and fluid ingress.It was further reported that the device¿s mode switch resistance was too high.The device also failed pretests for mode switch-test, oscillation frequency with frequency meter, sticky trigger and general condition.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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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.Additional narrative: 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 of sticky trigger identified during service and evaluation was confirmed.The assignable root cause was traced to component failure from wear.Udi: (b)(4).
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