DEPUY SYNTHES PRODUCTS LLC BATTERY FOR BATTERY POWER LINE II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.630 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Reporter¿s phone number was not provided.Reporter¿s contact name was not provided.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 will be submitted accordingly.
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Event Description
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This is report 1 of 2 for the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that two battery devices stopped working during the procedure.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.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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