TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP
Received Oct 11, 2018 · Event occurred Sep 11, 2018
Report 1220948-2018-00079 · MDR key 7957433
Device
Product problems
- Failure to Conduct
- Failure to Conduct
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
WE HAVE RECEIVED THE DEVICE FOR EVALUATION AND WE HAVE CONFIRMED THE REPORTED INCIDENT. INITIALLY, WE OBSERVED THE CONTROL UNIT TO OPERATE ON ALL SETTINGS AND FUNCTIONS. HOWEVER, UPON FURTHER TESTING, WE NOTICED A HESITATION IN THE OPERATION OF THE RESECTOR AND OBSERVED THAT THE HARNESS CONNECTOR WAS LOOSE. THE CONNECTOR WAS MOST LIKELY DAMAGED BY THE OPERATOR WHILE MOVING THE RESECTOR POWER CABLE NEGLIGENTLY OR DURING INSERTION/REMOVAL OF THE RESECTOR POWER CABLE INTO THE CONTROL UNIT. A LOOSE CONNECTOR CAN CAUSE INTERMITTENT CONNECTION AND CAN CAUSE THE HANDPIECE TO OPERATE INTERMITTENTLY. THERE WAS NO INJURY TO THE PATIENT. THE ISSUE WAS DETECTED DURING PRE-USE CHECK AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT CONTROL UNIT.
Description of Event or Problem
DURING PRE-USE CHECK, THE HANDPIECE FAILED TO OPERATE WHEN IT WAS CONNECTED TO THE CONTROL UNIT.