Catalog Number 0250080617 |
Device Problem
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 12/09/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.Mfg date: the date of manufacture is not known.(b)(4).
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Event Description
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It was reported that the insulation had been compromised.
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Manufacturer Narrative
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Alleged failure: burn on insulation at 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.Manufacture date is not known.Gtin: (b)(4).
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Event Description
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It was reported that the insulation had been compromised.
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Search Alerts/Recalls
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