CYSTO-URETHRO-FIBERSCOPE

Description of Event or Problem

IT WAS REPORTED THAT THE CUSTOMER HAS DETECTED URINARY TRACT INFECTION AFTER CYSTOSCOPY. NO CAUSE HAS BEEN IDENTIFIED YET.

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

DEVICE EVALUATION: THE FOLLOWING WAS FOUND DURING THE INVESTIGATION: THE SHAFT IS BENT BEHIND THE KINK PROTECTION. THE SHAFT'S COATING HAS DETACHED FROM THE SUBSTRUCTURE. THE IMAGE BUNDLE SHOWS TWO BROKEN FIBRES. THERE ARE RESIDUES ON THE LUER CONNECTOR. A VISUAL AND FUNCTIONAL TEST WAS CARRIED OUT ON THE ENDOSCOPE. THE HANDLE AND HOUSING SHOW SLIGHT SIGNS OF WEAR. THE SHAFT IS BENT BEHIND THE KINK PROTECTION, AND THE SHAFT'S COATING HAS DETACHED FROM THE SUBSTRUCTURE. THE IMAGE BUNDLE SHOWS TWO BROKEN FIBRES AND THERE ARE RESIDUES ON THE LUER CONNECTOR. THE CAUSES OF THESE PROBLEMS ARE DUE TO USAGE ERRORS OR/AND WEAR. IN ADDITION, THE RSB DEPARTMENT TOOK SAMPLES TO TEST FOR GERMS AND EVALUATED THE HYGIENE CHECKLIST PROVIDED BY THE CUSTOMER. THE ERROR DESCRIBED BY THE CUSTOMER " INFECTIONS AFTER CYSTOSCOPY" COULD BE NOT CONFIRMED. NO GERMS COULD BE DETECTED IN THE WORKING CANAL EITHER BEFORE OR AFTER SAMPLING. WHEN REVIEWING THE CHECKLIST, THE RSB DEPARTMENT FOUND THAT THE INSTRUCTIONS IN THE USER MANUAL ARE NOT ALWAYS FOLLOWED. FOR THIS REASON, A USER MISUSE ERROR IS TO BE ASSUMED WHICH LED TO THE INFECTION. THE CUSTOMER WAS INFORMED BY THE RSB DEPARTMENT ABOUT THE EVALUATION OF THE CHECKLIST AND GIVEN RECOMMENDATIONS FOR PREPARATION. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).