Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device had a malfunction was confirmed.It was found that there was a short circuit in the motor cable.The motor cable was replaced and the device was cleaned, tested and found to be fully functional.However, given the information provided we cannot discern a definitive root cause for the short circuit.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 06/25/2018 and passed all functional testing before being returned to the customer.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history lot : the service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 06/25/2018 and passed all functional testing before being returned to the customer.
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It was reported by the affiliate in singapore that during an unknown procedure, it was observed that the micro tornado hp w handcontrol device had an unspecified malfunction.During in-house engineering evaluation, it was determined that there was a short circuit in the motor cable on the device.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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