DEPUY SYNTHES PRODUCTS LLC BATTERY HANDPIECE/MODULAR FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 05.001.201 |
Device Problem
Overheating of Device (1437)
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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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Reporter's phone number was not provided.This device was returned for evaluation; however, during pre-repair assessment, it was determined that the device passed all specifications and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi ¿ (b)(4).
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Event Description
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It was reported from (b)(6) that the handpiece device was getting hot and did not work.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2019.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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