(b)(4).The device manufacture date is not known at this time.Alleged failure: cracked/peeling insulation at tip of shaft.Confirmed failure: cracked/peeling insulation at tip 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 reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
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