MalfunctionFAS
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°
Received Jun 9, 2026 · Event occurred May 15, 2026
Report 3007960282-2026-00119 · MDR key 25445659
Device
Generic name
Hf-resection Electrode
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22306DProduct problems
- Product Quality Problem
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
THE CUSTOMER REPORTED A BEND WAS FOUND IN THE INSERTION SECTION INVOLVING AN OLYMPUS HF-RESECTION ELECTRODE, LOOP. REPORTED. THERE WAS NO PATIENT INVOLVEMENT.