MalfunctionFGB
ASCEND SINGLE-USE FLEXIBLE URETEROSCOPE
Received May 7, 2026 · Event occurred Dec 11, 2025
Report 25111328 · MDR key 25111328
Device
Generic name
Ureteroscope And Accessories, Flexible/rigid
Manufacturer
Cook Medical LlcModel number
ASUS-86-300SCatalog number
G60339
Lot number
HA25F091
Patient
71 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
LASER FIBER BROKE DURING USE. CREATED HOLE/DEFECT IN DISPOSABLE FLEXIBLE URETEROSCOPE.