TRIVEX SYSTEM RESECTOR HANDPIECE
Received May 8, 2020 · Event occurred Apr 9, 2020
Report 1220948-2020-00058 · MDR key 10039085
Device
Generic name
Handpiece
Manufacturer
Lemaitre Vascular, Inc.Model number
7210387Catalog number
7210387
Lot number
YB02469
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE MALFUNCTION AT THIS TIME. THE MALFUNCTION WAS DETECTED DURING PREUSE CHECK. 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
DEVICE FAILED TO OPERATE DURING PRE-USE CHECK.