CYSTO-URETHRO-FIBERSCOPE
Received May 6, 2026
Report 1221826-2026-01019 · MDR key 25107502
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
- Urinary Tract Infection
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: SERIAL NUMBER HAS BEEN OBTAINED AND ENTERED IN SECTION D4 (B)(6). THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. 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
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).