MalfunctionFAS
HF-RESECTION ELECTRODE "PLASMABAND", BAND, MEDIUM, 24 FR., 12°-30°, ESG TCRIS
Received Apr 2, 2026 · Event occurred Feb 20, 2026
Report 3007960282-2026-00058 · MDR key 24768941
Device
Generic name
Endoscopic Electrosurgical Electrode, Bipolar, Single-use
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA47723SLot number
1000196549
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1 REPORTER FULL PHONE NUMBER: (B)(6). 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 HIGH FREQUENCY-RESECTION ELECTRODE TIP BROKE INSIDE PATIENT DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.