MalfunctionNLW
NA
Received May 24, 2012
Report 2134070-2012-00102 · MDR key 2591186
Device
Product problems
- Break
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGERY, THE CUTTING LOOP OF AN ENDOSCOPIC ELECTRODE BROKE INTO PIECES. THE BROKEN PIECE WAS RETRIEVED AND RETURNED.
Additional Manufacturer Narrative
FINAL INVESTIGATION SHOWED THAT THE CUTTING LOOP WAS BROKE IN TWO PLACES. THE UNATTACHED SECTION OF THE LOOP HAD BEEN RETRIEVED AND WAS RETURNED. IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE BREAK.