CYSTO-URETHRO-FIBERSCOPE
Received May 7, 2026
Report 1221826-2026-01029 · MDR key 25118018
Device
Generic name
Cysto-urethro-fiberscope
Manufacturer
Karl Storz EndovisionModel number
11272C1Catalog number
11272C1
Product problems
- Use of Device Problem
- Device Handling Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED AT THE TIME OF MDR SUBMISSION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
THE FOLLOWING WAS REPORTED: THE CUSTOMER HAS A FAULTY 11272C1 (LEAKING) CYSTO- URETHRO-FIBERSCOPE. APPARENTLY, TWO PATIENTS DEVELOPED A BLADDER INFECTION, WHICH LED TO THE DISCOVERY THAT THE ENDOSCOPE WAS LEAKING. DUE TO DEVELOPED BLADDER INFECTION THE EVENT IS DEEMED REPORTABLE.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION ADDED IN SECTION D4. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).