BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIDEO URETEROSCOPE 8.5 FR

    MDR report key: 16478494 · Received March 3, 2023

    Report

    Report Number
    1221826-2023-00041
    Event Type
    Death
    Date Received
    March 3, 2023
    Date of Event
    January 30, 2023
    Report Date
    October 5, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FGB
    PMA / PMN Number
    K141250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: THE EVALUATION REPORT FOUND INTERNAL PUNCTURE OF THE WORKING CHANNEL AND CRUSH IN THE SHAFT. PER COMPLAINT TEXT DATED ON (B)(6) 2023, THE SCOPE HAS SINCE BEEN DAMAGED FROM ALL OF THE HANDLING AFTER THE CASE. THE NOTED KINK IN THE SHAFT WAS NOT PRESENT DURING THE CASE OR AFTER WHEN OR LEADERSHIP AND ONSITE TECH WERE LOOKING AT THE SCOPE. IT HAS SHOWN UP SINCE THEN AND HAS BEEN NOTED BY THE ACCOUNT THAT THE DAMAGE WASN'T PRESENT PRIOR TO OR DURING THE CASE. IN ADDITION, PER THE PRODUCT EVALUATION REPORT, THE PRODUCT PASSED FOR CHANNEL PASSAGE IN ITS CURRENT CONDITION. THEREFORE, THE CRUSH IN THE SHAFT OF THE SCOPE NOTED AS PART OF PRODUCT EVALUATION WAS NOT A CONTRIBUTING FACTOR TO THE DEFECT. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION /INVESTIGATION RESULTS BECOME AVAILABLE, SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION:/ IT WAS NOTED BY THE KARL STORZ ONSITE ENDOSCOPIC SPECIALIST (OES) ON FEBRUARY 28, 2023 THAT THE DEVICE HAD BEEN DAMAGED FROM ALL OF THE ADDITIONAL HANDLING BY THE SITE AFTER THE CASE CONCLUDED. THE DEVICE WAS NOTED TO HAVE A KINK IN THE SHAFT THAT WAS NOT PRESENT DURING THE CASE OR AFTER WHEN THE OR LEADERSHIP AND THE OES WERE VIEWING THE SCOPE. THE DEVICE WAS RECEIVED AT THE MANUFACTURING SITE ON MARCH 8, 2023. IT WAS THEN SHIPPED TO KST RSB FOR BIOLOGICAL TESTING. KST RSB CONFIRMED RECEIPT OF THE DEVICE ON MARCH 30, 2023. KST REPROCESSING, STERILIZATION, AND BIOCOMPATIBILITY (RSB) PROVIDED THE BIOLOGICAL TEST RESULTS ON (B)(6), 2023 THAT SHOWED THE SAMPLING OF THE DEVICE IN THE CONDITION IN WHICH IT WAS RECEIVED FROM (B)(6) HOSPITAL HAD 3 CFU/ 20 ML OF STAPHYLOCOCCUS SP., NO S. AUREUS AND/OR BACILLUS SP. THE DEVICE WAS REPROCESSED ACCORDING TO IFU AFTER INITIAL PROBING: NO MICROORGANISM GROWTH WAS IDENTIFIED WHEN THE DEVICE WAS SAMPLED AGAINST AFTER BEING REPROCESSED IN ACCORDANCE WITH THE IFU. THESE RESULTS DEMONSTRATE THAT REPROCESSING ACCORDING TO THE IFU CAN PROPERLY STERILIZE THE DEVICE. WE WERE INFORMED ON 2/17/2023, THAT PRIOR TO THE SCOPES BEING SHIPPED TO THE MANUFACTURING SITE, THE LOCAL HEALTH DEPARTMENT CONDUCTED A WALK-THROUGH OF THE FACILITY'S STERILE PROCESSING DEPARTMENT AND TOOK THEIR OWN CULTURES FROM THE SCOPE ON (B)(6) 2023. WE WERE INFORMED THAT NO ABNORMALITIES WERE DETECTED. WE HAVE ASKED THE FACILITY FOR THEIR OFFICIAL RESULTS FROM THE HEALTH DEPARTMENT FROM THE FACILITY, BUT THE FACILITY HAS NOT PROVIDED THAT DATA. THE FACILITY USES RENUZYME ULTRA TO WASH THE SCOPE AND EITHER STERRAD OR VPRO TO STERILIZE THE SCOPE. ON 05 /19/23 , THE OES VERIFIED WITH FACILITY LOGS THAT THE SCOPE WAS STERILIZED BEFORE THIS CASE IN STERRAD, AND STERILIZED AFTER THE CASE IN VPRO. ADDITIONAL QUESTIONS TO THE MANUFACTURER WERE RECEIVED FROM THE FDA AND FORWARDED TO THE FACILITY. WE RECEIVED THE FOLLOWING INFORMATION FROM THE FACILITY ON MAY 17, 2023. THE PATIENT HAD THE FOLLOWING PRIOR ILLNESSES OR CONDITIONS PRIOR TO CYSTOSCOPY: CHRONIC DIAGNOSES - CEREBRAL PALSY, QUADRIPLEGIA, GLOBAL DEVELOPMENTAL DELAY, ECZEMA, MICROCEPHALY, BILATERAL NEPHROLITHIASIS, SCOLIOSIS, SEIZURE HISTORICAL/PREVIOUS DIAGNOSES - E. COLI BACTEREMIA AND UROSEPSIS, KIDNEY STONE, STAGHORN CALCULUS THE PROCEDURE WAS ELECTIVE. GUARDIAN DECLINED AUTOPSY. THE FACILITY DOES NOT HAVE ACCESS TO THE DEATH CERTIFICATE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN EVENT WITH A R11278VSUEK VIDEO URETEROSCOPE. ACCORDING TO THE INFORMATION RECEIVED, BOTH CYSTOSCOPES AND URETEROSCOPE WERE USED IN THIS CASE. CYSTOSCOPY WAS BEING PERFORMED. PER THE SITE, THEY STATED THAT THERE WASN'T ANYTHING UNUSUAL NOTED DURING THE CASE. CASE WAS COMPLETED WITHOUT ANY ISSUE. THERE WAS NO MALFUNCTION OF THE DEVICE DURING THE CASE. PATIENT DEVELOPED AN INFECTION WITHIN A 48-HOUR PERIOD AND HAD TO GO BACK TO THE HOSPITAL FOR TREATMENT. PATIENT SUBSEQUENTLY PASSED ON FEBRUARY 4TH DUE TO COMPLICATIONS FROM THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932394 VIDEO URETEROSCOPE 8.5 FR FLEXIBLE VIDEO URETEROSCOPE FGB KARL STORZ SE & CO. KG R11278VSUEK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female Congenital Anomaly| D