MalfunctionFAJ
ASCEND SINGLE-USE FLEXIBLE URETEROSCOPE
Received Feb 10, 2026
Report MW5183646 · MDR key 24307510
Device
Generic name
Cystoscope And Accessories, Flexible/rigid
Manufacturer
Cook Medical Llc.Model number
G60337Lot number
HA25H081
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WHEN USING DISPOSABLE URETEROSCOPE, COOK G60337, LOT # HA25H081, A LASER FIBER WAS INSERTED AND IN USE WHEN THERE WAS A SUDDEN AUDIBLE SOUND ACCOMPANIED BY A VISIBLE SPARK. THE DEVICE WAS NOTED TO HAVE SIGNIFICANT BENDING AT THE HANDLE-TO-SHAFT CONNECTION POINT, AND THE LASER FIBER APPEARED COMPROMISED. THE PHYSICIAN REPORTED TRANSIENT DISCOMFORT IN THE HAND/WRIST AT THE TIME OF MALFUNCTION. NO PATIENT HARM WAS IDENTIFIED OR REPORTED.