TRIVEX SYSTEM RESECTOR HANDPIECE
Received Feb 7, 2020 · Event occurred Jan 9, 2020
Report 1220948-2020-00016 · MDR key 9682813
Device
Product problems
- Defective Component
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 "EVALUTION" SINCE THE DEVICE IS STILL AT THE HOSPITAL. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE MALFUNCTION AT THIS TIME. THERE HAS BEEN NO SERIOUS INJURY ( 21 CFR 803.3 ) NOR WOULD THE MALFUNCTION RESULT IN A DEATH OR SERIOUS INJURY IF IT WAS TO REOCCUR SINCE THE RESECTOR 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 THE USER AT THE HOSPITAL RATHER THAN OUR HANDS-ON EVALUATION WITH THIS DEFECTIVE DEVICE ITSELF.
Description of Event or Problem
DURING PRE-USE CHECK, THE HANDPIECE FAILED TO OPERATE. DEVICE WAS NOT USED FOR THE PROCEDURE.