Catalog Number 0250040112 |
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 06/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available, it will be provided in future reports.(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.Alleged failure: insulation failure.Probable root cause: poor autoclave reliability, incorrect sterilization/reprocessing procedure, handling procedures, contact forces, product used beyond defined useful life.The alleged failure mode will be monitored for future reoccurrence.Mfr date: 9/29/2015.(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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