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Catalog Number QD8 |
Device Problems
Device Inoperable (1663); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.(b)(6).The actual device was returned for evaluation.The attachment device was evaluated and the reported condition that the device was not working was confirmed.An assessment was performed and it was observed that the device failed cutter insertion.Furthermore, it was determined that the bearings were worn out, loose and no longer in axial alignment which created a situation where the cutter was not able to be inserted and to pass through.The assignable root cause was determined to be due to worn out bearings from normal use and servicing over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Event Description
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It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the attachment device was not working.It was not reported if there was a delay in the procedure due to the event, or if a spare device was available for use.There was 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 2017.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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