TRIVEX SYSTEM RESECTOR HANDPIECE
Received Feb 28, 2019 · Event occurred Jan 29, 2019
Report 1220948-2019-00018 · MDR key 8379074
Device
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
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 HAS BEEN NO SERIOUS INJURY NOR WOULD THE MALFUNCTION RESULT IN A DEATH OR SERIOUS INJURY IF IT WAS TO REOCCUR SINCE THE HANDPIECE COULD NOT BE USED FOR THE PROCEDURE. 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. THE ISSUE WSA DETECTED DURING PRE-USE CHECK. HANDPIECE WAS NOT USED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT HANDPIECE.
Description of Event or Problem
HANDPIECE DID NOT OPERATE DURING PRE-USE CHECK.