CYSTO-URETHRO-FIBERSCOPE

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

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. SINCE A DEVICE-RELATED INFECTION CANNOT BE EXCLUDED AND THE ISSUE HAS OCCURRED REPEATEDLY, THE EVENT IS DEEMED REPORTABLE. SINCE SEVERAL EVENTS WERE REPORTED, THE FOLLOWING THREE CASES WERE LINKED TO ONE ANOTHER: 20260004292; 20260004295; 20260004299.