Catalog Number 0250080618 |
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 09/30/2015 |
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.
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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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