The reported device was not received for investigation; therefore, the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by:
poor autoclave reliability.Incorrect sterilization/reprocessing procedure.Handling procedures.Use error.Shear pin failure in handle.(proximal end if device).In sum, the reported failure could not be confirmed since the device was not received for investigation.
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