InjuryFAS
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°
Received Mar 23, 2026 · Event occurred Mar 4, 2026
Report 3007960282-2026-00052 · MDR key 24670724
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
- No Clinical Signs, Symptoms or Conditions
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 RESECTION ELECTRODE HAD BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC HYSTERORESECTION PROCEDURE AND WAS COMPLETE USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Remedial action
- Relabeling