FLEXIBLE FIBREOPTIC CYSTOURETHROSCOPE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IS PROVIDED IN SECTION D9 TO REFLECT THAT THE PRODUCT WAS RETURNED FOR EVALUATION. THE ITEM IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES ONLY: THE INITIAL MDR HAD THE CORRECT UDI NUMBER BUT THE FIRST DIGIT "0" WAS OMITTED. PLEASE SEE SECTION D4 OF THIS MDR FORM FOR THE UPDATED UDI NUMBER. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

THE CYSTO-URETHRO-FIBERSCOPE 11272C1 WAS RECEIVED ON 2023-11-27 AT THE MANUFACTURING SITE AND WAS THEREFORE AVAILABLE FOR INVESTIGATION. THE INVESTIGATION HAS BEEN COMPLETED ON THE 2024-02-08. VISUAL AND MICROSCOPICAL EXAMINATION OF THE DEVICE REVEALED THE FOLLOWING: THE SHAFT IS KINKED BEHIND THE KINK PROTECTION AND SEVERAL FIBERS IN THE EDGE AREA OF THE IMAGE BUNDLE ARE BROKEN. THE ARTICULATION COVER IS FOLDED AND EXTERNALLY DAMAGED. FURTHERMORE, THE VERTEBRAE AND THE LUER ARE CORRODED. DUE TO THE DEFECTS FOUND IN THE ARTICULATION COVER, THE FIBERSCOPE SHOULD NO LONGER HAVE BEEN USED AS DESCRIBED IN THE IFU. A SAMPLING FOR GERMS WAS REFRAINED DUE TO THE LONG TRANSPORT TIME, AS THIS COULD FALSIFY THE TEST RESULT. HOWEVER, A SEPARATE CHECKLIST WAS SENT TO THE CUSTOMER IN ORDER TO UNDERSTAND THE REPROCESSING PROCEDURE AND TO BE ABLE TO INTERPRET INDIVIDUAL STEPS. THE RESULTS OF THE REPROCESSING CHECKLIST INDICATE THAT THE REPROCESSING PROCESS DOES NOT FULLY COMPLY WITH THE REQUIREMENTS SET OUT IN THE ASSOCIATED IFU AS WELL AS IN CURRENT LITERATURE. THIS CONCERNS BOTH, THE CHEMICALS USED AS WELL AS VARIOUS INADEQUATE STEPS, E.G. DURING DRYING AND STORAGE. TO ENSURE PATIENT SAFETY, THE FIBERSCOPE 11272C1 MUST BE FULLY REPROCESSED. IF THE FIBERSCOPE IS CLASSIFIED BY THE OPERATOR AS A SEMI-CRITICAL MEDICAL DEVICE (CONTACT WITH MUCOUS MEMBRANES), THE FINAL DISINFECTION MUST COVER THE EFFECTIVE RANGE OF BACTERICIDAL,MYCOBACTERICIDAL, FUNGICIDAL AND VIRUCIDAL (KRINKO/BFARM RECOMMENDATION). FOR CLEANING AND DISINFECTION, WE RECOMMEND THE USE OF SUITABLE CHEMICALS THAT ARE LABELLED BY THE CHEMICAL MANUFACTURER FOR THESE REPROCESSING STEPS. THE CHEMICAL MANUFACTURER'S PRODUCT INFORMATION REGARDING APPLICATION PARAMETERS MUST BE OBSERVED. THE ENDOSCOPE MUST THEN BE SUFFICIENTLY DRIED (PREFERABLY WITH MEDICAL COMPRESSED AIR). IF DRYING IS INSUFFICIENT, MICROORGANISMS CAN MULTIPLY IN RESIDUAL MOISTURE AND THUS REPRESENT A SOURCE OF INFECTION. THE BFARM/KRINKO RECOMMENDATION POINTS OUT THE RISK OF GERM MULTIPLICATION WHEN STORED IN A MOIST STATE. ACCORDING TO THE TECHNICAL LITERATURE OF THE DGSV.EV AND ITS WORKING GROUP QUALITY, STORAGE IN A MOIST STATE CAN LEAD TO A PROLIFERATION OF GERMS. THE KNOWLEDGE GAINED IS ALSO MADE AVAILABLE TO THE CUSTOMER IN THE COURSE OF THE CURRENT COMPLAINT. BASED ON THE AVAILABLE INFORMATION AND THE RESULTS OF THE EXAMINATION, THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. THE ROOT CAUSE OF THE REPORTED ISSUE CAN BE TRACED BACK TO AN INSUFFICIENT REPROCESSING. INFORMATION IS CORRECTED WITH THE NEW INFORMATION IN SECTION H6. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE FRONT COVER OF THE PRODUCT (DEFECTIVE). INFECTIONS OCCURRED SEVERAL TIMES AFTER ENDOSCOPY. DUE TO THE REPORTED POSSIBLE INFECTIONS (CAUSALITY NOT CONFIRMED) THE RISK FOR SERIOUS DETERIORATION IN STATE OF HEALTH IS NOT NEGLIGIBLE.