InjuryFBO

CYSTO-URETHRO-FIBERSCOPE

Received Mar 20, 2026

Report 2020550-2026-00627 · MDR key 24655932

Device

Generic name

Cysto-urethro-fiberscope

Manufacturer

Karl Storz Se & Co. Kg

Model number

11272C1

Catalog number

11272C1

Product problems

Microbial Contamination of Device

Patient

NA · Unknown

Urinary Tract Infection

Narrative

Additional Manufacturer Narrative

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

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.