Catalog Number 0250080618 |
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 12/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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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.(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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The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: tip separating.Probable root cause: poor autoclave reliability, incorrect sterilization/reprocessing procedure, handling procedures, product used beyond defined useful life.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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