TRIVEX SYSTEM RESECTOR HANDPIECE
Received Dec 1, 2018 · Event occurred Oct 30, 2018
Report 1220948-2018-00102 · MDR key 8122019
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 NOT RECEIVED THE DEVICE FOR EVALUATION SINCE THE DEVICE IS STILL AT THE HOSPITAL. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT. THERE WAS NO IMPACT ON THE PATIENT'S HEALTH AS THE RESULT OF THIS INCIDENT. THE ISSUE WAS DETECTED DURING THE PRE-USE CHECK AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT HANDPIECE IN STOCK. THE DEVICE WAS NON-FUNCTIONAL AND THEREFORE THE MALFUNCTION WAS DETECTED PRIOR TO THE CASE. THERE HAS BEEN NO SERIOUS INJURY (SECTION 2.13) NOR WOULD THE MALFUNCTION RESULT IN A DEATH OR SERIOUS INJURY IF IT WAS TO REOCCUR I.E THE DEVICE NEVER FUNCTIONED AT ANY POINT OF THE CASE AND THEREFORE THE PATIENT WAS NEVER EXPOSED OR POTENTIALLY EXPOSED, TO THE DEVICE. HOWEVER, WE HAVE DECIDED TO REPORT THE INCIDENT SINCE OUR EVALUATION WAS BASED ON THE REPORTED DEFECT FROM OUR SALES REP. AND THE USER AT THE HOSPITAL RATHER THAN OUR HANDS-ON EVALUATION WITH THIS DEFECTIVE DEVICE ITSELF. OUR SALES REP. REACHED OUT TO THE TEAM INVOLVED IN THE SURGERY FOR ADDITIONAL INFORMATION. HOWEVER, NEITHER THE SURGEON OR THE TECH WAS AVAILABLE FOR DISCUSSION ON THIS CASE AT THE TIME.
Description of Event or Problem
THE CONTROL UNIT DISPLAYED AN ERROR CODE WHEN THE RESECTOR WAS PLUGGED INTO THE CONTROL UNIT. THE CONTROL UNIT WAS FLASHING ORANGE UPON CONNECTION.