BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTH NET - FOREIGN BODY - STANDARD

    MDR report key: 1881891 · Received October 20, 2010

    Report

    Report Number
    MW5017853
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    October 16, 2010
    Report Date
    October 19, 2010
    Manufacturer
    US ENDOSCOPY
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING A ROTH NET TO RETRIEVE A FOOD BOLUS FROM THE ESOPHAGUS, THE NET TIGHTENED UP AND REQUIRED A FAIR AMOUNT OF PRESSURE TO HOLD CLOSED. ON THE SECOND PASS, THE NET WAS EVEN MORE DIFFICULT TO CLOSE AND WOULD NOT CLOSE COMPLETELY. A KINK WAS NOTED WHERE THE WIRE ATTACHED TO THE WHITE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTH NET - FOREIGN BODY - STANDARD ENDOSCOPY ROTH NET KOG US ENDOSCOPY 23432

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR