CYSTO-URETHRO-FIBERSCOPE
Received Mar 24, 2026
Report 1221826-2026-00631 · MDR key 24680659
Device
Generic name
Cysto-urethro-fiberscope
Manufacturer
Karl Storz EndovisionModel number
11272C1Catalog number
11272C1
Product problems
- Microbial Contamination of Device
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Urinary Tract Infection
Narrative
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. CROSS REFERENCE MDR: (B)(4). THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
ACCORDING TO THE CUSTOMER, SEVERAL PATIENTS REPORTED URINARY TRACT INFECTIONS AFTER TREATMENT. DESPITE PROPER DISINFECTION AND CORRECT REPROCESSING, THE CUSTOMER NOTED THAT THE DEVICE REPEATEDLY SHOWED MICROBIOLOGICAL ABNORMALITIES WITH EVIDENCE OF BACTERIAL CONTAMINATION. CROSS REFERENCE MDR: 1221826-2026-00633, 9610617-2026-00627.
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).