Catalog Number 0250080617 |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/30/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported the insulation is compromised.
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Manufacturer Narrative
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(b)(4).The device manufacture date is not known.Alleged failure: burn on insulation at shaft, bent shaft.Confirmed failure: burn on insulation at shaft.Probable root cause: poor autoclave reliability; incorrect sterilization/reprocessing procedure; handling procedures; contact forces; product used beyond defined useful life.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported the insulation is compromised.
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Search Alerts/Recalls
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