TRIVEX SYSTEM RESECTOR HANDPIECE
Received Feb 14, 2020 · Event occurred Oct 17, 2019
Report 1220948-2020-00018 · MDR key 9712014
Device
Generic name
Handpiece
Manufacturer
Lemaitre Vascular, Inc.Model number
7210387Catalog number
7210387
Lot number
YB02293
Product problems
- Defective Device
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. 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.