Catalog Number 0250080230 |
Device Problems
Crack (1135); Peeled/Delaminated (1454)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/29/2015 |
Event Type
malfunction
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Manufacturer Narrative
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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 at the tip of the shaft was cracked/peeling.
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Manufacturer Narrative
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"the following repair and service diagnostic codes were identified: cracked/peeling insulation at tip of shaft.Replaced handle.The following was observed: cracked / peeling insulation at tip of shaft.The handle was replaced.This does confirm the alleged failure mode of: insulation damage.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 at the tip of the shaft was cracked/peeling.
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Search Alerts/Recalls
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