BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTOSCOPE

    MDR report key: 17086168 · Received June 7, 2023

    Report

    Report Number
    MW5118259
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    June 5, 2023
    Report Date
    June 7, 2023
    Manufacturer
    UNK
    Product Code
    FAJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A REPORTER CALLED TO REPORT THAT A CYSTOSCOPE BROKE WHILE THE DOCTOR IS TRYING TO REMOVE THE STENT PLACED IN HER URETER FOR KIDNEY STONE REMOVAL. SHE SAID THE PROCEDURE WAS ON (B)(6), AND SHE WENT BACK IN ABOUT A WEEK TO HAVE THE STENT TAKEN OUT. SHE SAID SHE WAS UNDER THE IMPRESSION THEY WOULD GIVE HER A NUMBING AGENT BEFORE THEY TRY TO PULL THE STENT OUT. APPARENTLY, THEY DID NOT DO THAT AND SHE EXPERIENCED STABBING PAIN TO THE POINT SHE WAS GRABBING THE TECHS. SHE SAID THE DOCTOR USED A CYSTOSCOPE TO REMOVE THE STENT AND SHE THOUGHT SOMETHING BROKE AND THE DOCTOR WAS HAVING PROBLEMS TO REMOVE THE STENT. SHE SAID THE DOCTOR THROW AWAY THE BROKEN DEVICE AND GOT ANOTHER ONE AND FINALLY REMOVED THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275663 CYSTOSCOPE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FAJ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female