DEPUY SYNTHES PRODUCTS LLC BATTERY RECIPROCATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.715 |
Device Problem
Intermittent Energy Output (4025)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device evaluation: 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 due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was determined that the motor of the battery reciprocator device was not functioning and was defective.It was determined that the motor was working intermittently and had no function.It was further determined that the device failed pretest for functional test.It was noted in the service order that the device had an undetermined malfunction.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 2019.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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