MalfunctionDWQ
TRIVEX MDU
Received Aug 13, 2004 · Event occurred Jul 13, 2004
Report 1643264-2004-00022 · MDR key 618867
Device
Generic name
*
Manufacturer
Smith & Nephew, Inc.-endoscopy DivisionModel number
7210387Catalog number
7210387
Lot number
*
Product problems
- Replace
- Self-Activation or Keying
Patient
UNKNOWN
- Surgery, prolonged
- Surgical procedure, delayed
Narrative
Description of Event or Problem
DURING A PHLEBECTOMY PROCEDURE, THE HANDPIECE WAS NOT STARTING AND STOPPING AS EXPECTED. THE HANDPIECE WAS RUNNING ON ITS OWN. THERE WAS A ONE HOUR DELAY TO REMOVE AND REPLACE THE CONTROL UNIT AND HANDPIECE TO GET IT RUNNING FOR THE COMPLETION OF THE PROCEDURE. NO PT INJURY WAS NOTED.