HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°/16°, ESG TURIS
Received Apr 23, 2026 · Event occurred Dec 13, 2024
Report 3007960282-2026-00086 · MDR key 24972784
Device
Generic name
Endoscopic Electrosurgical Electrode, Bipolar, Single-use
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22702SLot number
1000150271
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: A BROKEN CAUTERY TIP. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HF-RESECTION ELECTRODE EXHIBITED A BROKEN CAUTERY TIP. THERE WAS NO PATIENT INVOLVEMENT.