MalfunctionJOS
24FR 30 CUTTING LOOP ELECTRODE, .014 (6BX)
Received Jun 21, 2012 · Event occurred Jun 1, 2012
Report 2936485-2012-00342 · MDR key 2634091
Device
Generic name
Cutting Loop Electrode
Manufacturer
Stryker Endoscopy San JoseCatalog number
0504880414
Lot number
STRGJ02
Product problems
- Detachment Of Device Component
- Component Falling
Patient
UNK
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CUTTING LOOP DETACHED FROM THE ELECTRODE DURING AN ENDOMETRIAL ABLATION PROCEDURE. IT WAS FURTHER REPORTED THAT THE LOOP WAS RETRIEVED FROM THE PT.
Additional Manufacturer Narrative
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.