The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The initial failure of the device was alleged as cracked/peeling insulation at shaft, but upon further investigation it was confirmed that the actual failure was bent shaft.The confirmed failure mode still constitutes a breach in insulation.Probable root cause: poor autoclave reliability, incorrect sterilization/reprocessing procedure, handling procedures, contact forces, product used beyond defined useful life.Manufacture date is not known.(b)(4).
|