InjuryFBO
CYSTO-URETHRO-FIBERSCOPE
Received May 6, 2026
Report 2020550-2026-01019 · MDR key 25107407
Device
Generic name
Cysto-urethro-fiberscope
Manufacturer
Karl Storz EndovisionModel number
11272C1Catalog number
11272C1
Product problems
- Use of Device Problem
Patient
NA · Unknown
- Urinary Tract Infection
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.