MalfunctionFAS
N.A.
Received Aug 1, 2025 · Event occurred Jul 15, 2025
Report 22685831 · MDR key 22685831
Device
Generic name
Electrode, Electrosurgical, Active, Urological
Manufacturer
Karl Storz Endoscopy-america, Inc.Model number
27040GP130-SLot number
37AE0451
Product problems
- Break
Patient
47 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WHILE USING THE BIPOLAR CUTTING LOOP IN THE BLADDER, THE LOOP PART BROKE OFF OF THE INSTRUMENT. THE PART THAT WAS BROKEN OFF WAS RETRIEVED. MANUFACTURER RESPONSE FOR ELECT ELCTRSRG CUT LOOP .3MM STER DISP BI LF, (BRAND NOT PROVIDED) (PER SITE REPORTER). VENDOR SENT REPLACEMENT.