DEPUY SYNTHES POWER TOOLS HAND SWITCH F/EPD; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.012 |
Device Problem
Failure to Shut Off (2939)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).Device manufacture date is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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This is report 2 of 3 of the same event.It was reported from india that the after plugging the electric pen drive device to the electric socket the device ran continuously.The electric pen drive device was in use with the cable device and hand switch device.The event did not occur during a surgical procedure.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device passed all manufacturing specifications.Therefore, the reported condition was not duplicated and confirmed.An assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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