DEPUY SYNTHES POWER TOOLS ELECTRIC SYSTEMS FOOT CONTROL; MOTOR, DRILL, ELECTRIC - FOOT CONTROL
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Catalog Number E-FP |
Device Problems
Cut In Material (2454); Material Protrusion/Extrusion (2979)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/18/2014 |
Event Type
malfunction
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Event Description
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It was reported that the cord of the foot control device cord was nicked and cut in three different places and wires were exposed.It was not reported if the device was used in surgery.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There was no patient involvement.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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Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was duplicated and confirmed.The assignable root cause was determined to the user allowing the cord to come into contact with a sharp object.This was further defined as misuse, abuse and/ or user error.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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