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 02/24/2016 |
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 manufacture date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that insulation was cracked / peeling at tip of shaft.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence."the following repair and service diagnostic codes were identified based on service request.Cracked/peeling insulation at tip of shaft; replaced handle.The following was observed: cracked / peeling insulation at tip of shaft.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.".
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Event Description
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It was reported that insulation was cracked / peeling at tip of shaft.
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Search Alerts/Recalls
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