DEPUY SYNTHES POWER TOOLS CABLE F/ELECTRIC PEN DRIVE+SMALL ELECTRI; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.025 |
Device Problem
Failure to Shut Off (2939)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/10/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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This is report 4 of 5 for the same event.It was reported from (b)(6) that during an unspecified veterinary surgery, it was discovered that the handpiece device kept turning after the doctor released the manual control.According to the report, the device was in use with a console device, two cable devices and a hand switch device.There were no delays in the surgical procedure.It was not reported if spare devices were available for use.There was no human patient involvement as this was a veterinary procedure.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 serial number was documented as (b)(4) on the initial report.Upon complaint review, it was determined that this is incorrect as the device has a lot number of 7872743 instead.Therefore, the lot number field has been updated as 7872743 to reflect the correct information.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device worked well and no failure could be found.Therefore, the reported condition was not 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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