MalfunctionFAS
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, LONG, 24 FR., 12°, ESG TURIS
Received Apr 14, 2026 · Event occurred Mar 17, 2026
Report 3007960282-2026-00069 · MDR key 24873340
Device
Product problems
- Material Twisted/Bent
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 HF-RESECTION ELECTRODE PLASMALOOP WAS BENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.