BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARLOW BALLOON CANNULA

    MDR report key: 75929 · Received March 13, 1997

    Report

    Report Number
    MW1010939
    Event Type
    Malfunction
    Date Received
    March 13, 1997
    Date of Event
    January 16, 1997
    Report Date
    February 27, 1997
    Manufacturer
    MARLOW SURGICAL TECHNOLOGIES, INC.
    Product Code
    GEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON CANULA WAS INSERTED INTO ABDOMEN FOR LAPROSCOPIC CHOLECYSTECTOMY. ON CAMERA STAFF AND SURGEON WATCHED THE BALLOON DEFLATE AS INFLATED. THE SURGEON DID NOT FEEL THAT SHE HAD KNICKED THE BALLOON DURING INSERTION. SURGEON WANTED CO TO BE MADE AWARE. A SECOND BALLOON WAS INSERTED WITHOUT PROBLEM. PT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARLOW BALLOON CANNULA PRODUCT # ML-10120 GEA MARLOW SURGICAL TECHNOLOGIES, INC. * 58-273-12

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR