InjuryFAS
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°
Received Mar 31, 2026 · Event occurred Mar 4, 2026
Report 3007960282-2026-00055 · MDR key 24742916
Device
Generic name
Electrode, Electrosurgical, Active, Urological
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22507DLot number
1000189767
Product problems
- Break
Patient
Not reported
- Uterine Perforation
- Bowel Perforation
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THE HF-RESECTION ELECTRODE LOOP BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC HYSTERORESECTION PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Remedial action
- Relabeling