MalfunctionFAS
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
Received Apr 2, 2026 · Event occurred Feb 22, 2026
Report 3007960282-2026-00056 · MDR key 24766706
Device
Generic name
Hf-resection Electrode
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22302DLot number
1000111735
Product problems
- Break
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1 - INITIAL REPORTER ESTABLISHMENT FULL NAME: (B)(6). 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 HIGH FREQUENCY-RESECTION ELECTRODE CUTTING LOOP FRACTURED DURING A LAPAROSCOPIC AND HYSTEROSCOPIC MYOMECTOMY. THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.