(b)(4).The following repair diagnostic codes were identified: cracked/peeling insulation at tip of shaft this does confirm the alleged failure mode of [cracked insulation].Probable root cause: poor autoclave reliability.Incorrect sterilization/reprocessing procedure.Handling procedures.Contact forces.Product used beyond defined useful life.The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.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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