HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TURIS
Received May 29, 2026 · Event occurred Jan 20, 2025
Report 3007960282-2026-00116 · MDR key 25333542
Device
Generic name
Endoscopic Electrosurgical Electrode, Bipolar, Single-use
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22706SProduct problems
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS TRACED TO CAUSE TRACED TO COMPONENT FAILURE EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. 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
THE CUSTOMER RETURNED THE HF-RESECTION ELECTRODE "PLASMALOOP TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATION INDICATES THAT THE PLASMA LOOP AND SHAFT WERE BENT. THERE WAS NO PATIENT INVOLVEMENT.