MalfunctionDWQ
TRIVEX SYSTEM RESECTOR HANDPIECE
Received Feb 14, 2020 · Event occurred Jan 17, 2020
Report 1220948-2020-00019 · MDR key 9714615
Device
Generic name
Handpiece
Manufacturer
Lemaitre Vascular, Inc.Model number
7210387FCatalog number
7210387F
Lot number
YB02303
Product problems
- Loose or Intermittent Connection
- Loose or Intermittent Connection
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.
Description of Event or Problem
DURING PRE-USE CHECK, THE HANDPIECE FAILED TO OPERATE PROPERLY. THE BLADE ROTATED INTERMITTENTLY EVEN WHEN THE RUN BUTTON WAS NOT PRESSED.