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: 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." furthermore, reportability decision was check for consistency.".
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