Catalog Number 0250080617 |
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 03/11/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.(b)(4).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 at tip of the shaft was cracked / peeling.
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Manufacturer Narrative
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(b)(4).The device manufacture date is not known at this time.Alleged failure: insulation damage.Confirmed failure: cracked/peeling insulation at middle of shaft.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 failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that insulation at tip of the shaft was cracked / peeling.
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Search Alerts/Recalls
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