CYSTO-URETHRO-FIBERSCOPE

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.

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).

Additional Manufacturer Narrative

AN INCORRECT ADDRESS WAS PROVIDED IN SECTION D3, G1 AND INCORRECT MANUFACTURE NUMBER IN THE INITIAL REPORT. THIS SUPPLEMENTAL REPORT IS TO PROVIDE THE CORRECT CONTACT INFORMATION FOR THIS SECTION. CORRECTION: MDR WAS PREVIOUSLY FILLED WAS INCORRECT ROUTING NUMBER, THE CORRECT ROUTING NUMBER SHOULD HAVE BEEN 1221826-2026-00627, SINCE THE INITIAL MDR WAS FILLED WITH 9610617-2026-00627 WE WILL CONTINUE ON USING IT FOR ADDITIONAL SUPPLEMENTAL THAT WILL BE CREATED FOR THIS MDR. 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: 20260004299_201095177, 20260004295_ 201095176. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

CROSS REFERENCE MDR: 1221826-2026-00631, 1221826-2026-00633.