BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES

    MDR report key: 3181435 · Received June 12, 2013

    Report

    Report Number
    3181435
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    April 18, 2013
    Report Date
    June 12, 2013
    Manufacturer
    COOK MEDICAL
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    PUT THE BALLOON DOWN THE SCOPE. TRIED TO INFLATE. WATER WAS COMING OUT OF THE BALLOON. PROCEDURE COMPLETED WITH A DIFFERENT DEVICE. NO HARM TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BALLOON DILATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267232 HERCULES DILATOR, ESOPHAGEAL KNQ COOK MEDICAL * W3247097

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR