DEPUY SYNTHES PRODUCTS LLC BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.710 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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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.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).
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Event Description
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It was reported from (b)(6) that during service and evaluation, it was determined that the battery oscillator device had a fractured trigger, component damage and sticky trigger.It was further determined that the device failed pretest for check for sticky trigger.It was noted in the service order that the device did not work.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.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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