MalfunctionNLW
NA
Received May 24, 2012
Report 2134070-2012-00074 · MDR key 2591238
Device
Product problems
- Failure to Align
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN ENDOSCOPIC ELECTRODE HAD AN IMPROPER ANGLE TO IT.
Additional Manufacturer Narrative
FINAL INVESTIGATION SHOWED THAT THE LOOP OF THE DEVICE WAS BROKEN, AND THERE WERE BURNED AREAS ON THE LOOP AND SHEATHING. IT APPEARED THAT A PIECE OF THE ELECTRODE LOOP WAS MISSING.