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Patient 1
WE HAVE RECEIVED THE DEVICE FOR EVALUATION. WHEN THE HANDPIECE WAS CONNECTED TO THE CONTROL UNIT, IT FLASHED GREEN INDICATING AN ISSUE WITH THE HANDPIECE. UPON DISASSEMBLY, WATER WAS OBSERVED INSIDE THE CORE TUBE AND UNDER THE PC BOARD. THE SWITCH ASSEMBLY AREA WAS FOUND TO BE ACCEPTABLE. WHEN THE MOTOR WAS TESTED IN A STANDALONE MODE, THE LOCK REED SWITCH WAS ACTIVATED BUT THE MOTOR ROTATED HESITANTLY SUGGESTING SOME DRAG INSIDE THE MOTOR. THIS EXTRA DRAG COULD HAVE PREVENTED THE MDU DRIVE SHAFT FROM ROTATING WHEN THE MOTOR WAS OPERATING UNDER A LOAD - WITH THE MDU DRIVE SHAFT AND THE RESECTOR CONNECTED AT THE USER FACILITY. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE A MOTOR DAMAGE DUE TO WATER INGRESS. THE SEAL FAILURE WAS LIKELY DUE TO WEAR FROM REPEATED CLEANING, USE AND STERILIZATION THAT LED TO WATER INGRESS INTO THE INNER COMPONENTS OF THE HANDPIECE THAT AFFECTED THE MOTOR FUNCTIONALITY. WE CURRENTLY HAVE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) OPEN TO ADDRESS THIS ISSUE. THERE WAS NO INJURY TO THE PATIENT. THE MALFUNCTION WAS DETECTED PRIOR TO THE CASE. THE DEVICE NEVER FUNCTIONED AT ANY POINT OF THE CASE AND THEREFORE THE PATIENT WAS NEVER EXPOSED TO THE DEVICE.