The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found a discolored cable and frayed lanyard.A functional evaluation found a jammed motor.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.The complaint was confirmed and the root cause has been associated with a mechanical component failure.Factors that could have contributed to the reported event include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time or one or more of the motor phases shorting out.
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It was reported that during the set up before the surgery the motor drive unit was not working properly, could cause a short circuit on the shaver box, there was no overheating, arcing, sparking, error message or smoking of the device.No patient injuries or delay reported.Smith and nephew back-up device was available to complete the surgery.Results of investigation have concluded the mdu functional evaluation found a jammed motor; therefore, makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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