BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETERSCOPE

    MDR report key: 2102323 · Received May 19, 2011

    Report

    Report Number
    MW5020693
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 19, 2011
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    FGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING FLEXIBLE URETEROSCOPE IN LEFT URETER, TIP WAS CURVED (IN SHAPE OF C) AND PHYSICIAN UNABLE TO GET TIP OF SCOPE TO STRAIGHTEN. PHYSICIAN ATTEMPTED TO STRAIGHTEN WITH A GUIDE WIRE. PHYSICIAN REMOVED SCOPE WITHOUT MUCH DIFFICULTY. AFTER PHYSICIAN EXAMINED URETER IT APPEARED DAMAGED. PHYSICIAN ORDERED PT TO BE MOVED TO AN OPEN OPERATING ROOM FOR LAPAROTOMY WITH REPAIR OF LEFT URETER. LEFT URETERAL REIMPLANTATION DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETERSCOPE FGB GYRUS ACMI, INC GYRUS ACMI AUR-7

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention