BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIDEO URETEROSCOPE 8.5 FR

    MDR report key: 17211986 · Received June 27, 2023

    Report

    Report Number
    2020550-2023-00040
    Event Type
    Death
    Date Received
    June 27, 2023
    Date of Event
    January 30, 2023
    Report Date
    June 27, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FGB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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).

    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 (B)(6) DUE TO COMPLICATIONS FROM THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028108 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 Death