BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIBLE FIBREOPTIC CYSTOURETHROSCOPE

    MDR report key: 18375032 · Received December 21, 2023

    Report

    Report Number
    2020550-2023-00399
    Event Type
    Injury
    Date Received
    December 21, 2023
    Report Date
    December 21, 2023
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FBO
    UDI-DI
    04048551226100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153742 FLEXIBLE FIBREOPTIC CYSTOURETHROSCOPE CYSTO-URETHRO-FIBERSCOPE FBO KARL STORZ ENDOVISION 11272C1 04048551226100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other