(b)(4).The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.The following repair diagnostic codes were identified: one (1) (cracked/peeling insulation at tip of shaft).This does confirm the alleged failure mode of [insulation scan failed].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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