MalfunctionDWQ
TRIVEX SYSTEM
Received Feb 26, 2020 · Event occurred Feb 21, 2020
Report 9752969 · MDR key 9752969
Device
Generic name
Stripper, Vein, External
Manufacturer
Lemaitre Vascular, Inc.Product problems
- Loss of Power
- Noise, Audible
Patient
17520 DA
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
LEFT SIDE OF TRIVEX STOPPED WORKING WHEN MD WENT TO USE IT FOR PROCEDURE ON PATIENT. TRIVEX DEVICE WAS SET UP PRIOR TO CASE AND PASSED ALL INITIAL CHECKS. TUMESCENCE WAS CONNECTED TO LEFT SIDE OF TRIVEX DEVICE FOR TRANSILLUMINATED PHLEBECTOMY LEFT LOWER LEG. MD TESTED MACHINE TO USE AND A NOISE WAS HEARD, AND PUMP STOPPED. MD ASSESSED SITUATION AND EVERYTHING CHANGED TO RIGHT SIDE OF MACHINE AND PROCEEDED WITHOUT DIFFICULTY. NO INJURY TO PATIENT.