Alleged failure: friction/impaired rotation of rotating knob, burn on insulation at shaft.Confirmed failure: friction/impaired rotation of rotating knob, 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.Mfg date: the date of manufacture is not known.(b)(4).
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