TRIVEX SYSTEM RESECTOR HANDPIECE
Received May 2, 2019 · Event occurred Apr 5, 2019
Report 1220948-2019-00051 · MDR key 8573479
Device
Product problems
- Intermittent Loss of Power
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
WE HAVE RECEIVED THE DEVICE FOR EVALUATION. THE HOUSING AND POWERCORD WERE VISUALLY INSPECTED AND WERE FOUND TO BE ACCEPTABLE. THE HANDPIECE WAS THEN CONNECTED TO A CONTROL UNIT. THE DRIVE SHAFT ROTATED PROPERLY WHEN THE RUN OR THE WINDOW LOCK BUTTON WERE PRESSED. WE WERE UNABLE TO REPLICATE THE REPORTED INTERMITTENT FAILURE WITH THIS DEVICE AS IT OPERATED PROPERLY IN ALL SPEEDS AND SETTINGS DURING OUR EVALUATION. UPON FURTHER INSPECTION, WE NOTED BLACK MARKER LINES ON THE HANDPIECE'S CONNECTOR END SUGGESTING THAT THE USER MAY HAVE REMOVED THE POWER CORD AT SOME POINT. UPON DISASSEMBLY, THERE WERE NO SIGNS OF COMPONENT MALFUNCTION OR ASSEMBLY ERROR. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THE DEVICE NOR DID THIS INCIDENT RESULTED IN ANY SIGNIFICANT DELAY IN THE PROCEDURE. SURGEON WAS ABLE TO COMPLETE THE PROCEDURE BY CHANGING TO A DIFFERENT HANDPIECE. AT THIS TIME, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT AS WE WERE UNABLE TO REPLICATE THE REPORTED FAILURE. IT IS POSSIBLE THAT THERE WAS A HIGH CURRENT SURGE IN THE HANDPIECE DURING THE PROCEDURE. THIS DEVICE IS PROGRAMMED WITH A SAFETY FEATURE THAT ALLOWS IT TO STOP ROTATING WHEN A HIGH CURRENT FLOW IS DETECTED IN THE CIRCUIT.
Description of Event or Problem
SURGEON REPORTED THAT DURING THE TRANSILLUMINATED PHLEBECTOMY (TIPP) PROCEDURE, THE HANDPIECE WORKED INTERMITTENTLY. HE THEN SWITCHED TO ANOTHER HANDPIECE TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THE INCIDENT.