Alleged failure: coating peeling off handle|burn on insulation at shaft|.Confirmed failure: coating peeling off handle|burn on insulation at 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.The device manufacture date is not known.(b)(4).
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