Medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation noted the device was disassembled to inspect the internal components, and it was noted that the inner blade was sheared off towards its proximal end.It was reported that the device would not oscillate.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
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According to the reporter, during a procedure, the device was blunt.The shaver did not optimally shave the pathology of the uterus.A new device was opened to complete the case.There was no patient injury.Medtronic initial investigation on the device noted that the inner blade was sheared off towards its proximal end.Medtronic investigation communication state that there was nothing sheared off form the device and nothing fell into the patient's cavity.
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