MalfunctionFAS
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TURIS
Received Apr 11, 2026 · Event occurred Mar 13, 2026
Report 3007960282-2026-00066 · MDR key 24846508
Device
Generic name
Endoscopic Electrosurgical Electrode, Bipolar, Single-use
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22706SLot number
1000219427
Product problems
- Break
Patient
NA · Unknown
- 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 LOOPS HAD BROKE. THE ISSUE WAS FOUND DURING A THERAPEUTIC REMOTE TERMINAL UNIT (RTU) AND COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT INVOLVEMENT.