DERMATOME AN HANDPIECE

Additional Manufacturer Narrative

THIS INCIDENT IS BEING RECORDED UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN NORWAY. E1: TELEPHONE-(B)(6). THE DEVICE WILL BE RETURNED FOR ANALYSIS, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY THE DEVICE WAS RUNNING AT VARIABLE SPEED AND SOMETIMES STOPPED. DEVICE WAS NOTED TO BE LEAKING NITROGEN GAS BETWEEN HANDPIECE AND HOSE. WHEN GAS PRESSURE WAS LOW HAD TO SQUEEZE THE HOSE AND DERMATOME CONNECTIONS TOGETHER TO GET NORMAL SPEED. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT OR SURGICAL DELAY. DILIGENCE IS COMPLETE.