TRIVEX SYSTEM RESECTOR HANDPIECE

Additional Manufacturer Narrative

WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. WHEN THE HANDPIECE WAS CONNECTED TO A CONTROL UNIT AND THE POWER BUTTON WAS PRESSED, MOTOR ROTATED AS EXPECTED. HOWEVER, WHEN RELEASING THE BUTTON, THE MOTOR KEPT SPINNING FOR A SHORT SPAN OF TIME. UPON EXAMINATION, THE WINDOW LOCK BUTTON WHICH IS USED TO POSITION THE BLADES DURING THE SURGERY WAS FOUND TO BE NON-FUNCTIONING, AS PRESSING THE BUTTON WOULD NOT ENGAGE THE DRIVE. WHEN THE HOUSING WAS DISASSEMBLED, WE OBSERVED FLUID INSIDE THE CORE OF THE HANDPIECE. THE REED SWITCH ON THE BOARD FOR THE WINDOW LOCK BUTTON WAS FOUND TO BE NON-OPERATIONAL. WHEN THE TERMINALS WERE INTENTIONALLY SHORTED OR THE SWITCH HAD MAGNET CONTACT, THERE WAS A >3V READING FROM THE MULTIMETER. THIS WOULD NOT PROVIDE THE APPROPRIATE VOLTAGE TO HAVE THE WINDOW LOCK FEATURE ENGAGE. WHEN THE BUTTON WAS RELEASED, THE VOLTAGE RETURNED TO NEARLY 4 V, WHEN IT WAS SUPPOSED TO RETURN TO 5V SUGGESTING A DAMAGE TO THE BOARD. WHEN THE LOAD WAS REMOVED FROM THE MOTOR AND WAS TURNED ON, WE COULD HEAR A GRINDING NOISE COMING FROM THE MOTOR. THE ROOT CAUSE WAS DETERMINED TO BE MOTOR AND REED SWITCH FAILURE DUE TO WATER INGRESS INTO THE HANDPIECE. WE CURRENTLY HAVE A CORRECTIVE ACTION OPENED TO RESOLVE THIS ISSUE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS ISSUE.

Description of Event or Problem

SURGEON STATED THAT WHILE THE DEVICE WAS SITTING IDLE ON THE STERILE FIELD, IT STARTED TURNING BY ITSELF.