MalfunctionNLW
NA
Received May 24, 2012
Report 2134070-2012-00095 · MDR key 2591228
Device
Product problems
- Break
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN ELECTRODE BROKE DURING A PROCEDURE.
Additional Manufacturer Narrative
FINAL INVESTIGATION SHOWED THAT THE CUTTING LOOP OF THE DEVICE WAS BROKEN. THE PIECE THAT BROKE OFF WAS RETURNED WITH THE DEVICE. IT WAS NOT POSSIBLE TO DETERMINE WHAT CAUSED THE CUTTING LOOP TO BREAK DURING USE.