BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN OMS BALLOON

    MDR report key: 789464 · Received November 20, 2006

    Report

    Report Number
    1219930-2006-00483
    Event Type
    Malfunction
    Date Received
    November 20, 2006
    Date of Event
    November 7, 2006
    Report Date
    November 16, 2006
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, A ROUND PIECE POPPED OFF THE HOUSING INTO THE OPERATIVE SITE. THE ROUND PIECE WAS RETRIEVED AND DISCOVERED TO BE THE PNEUMO SEAL WITHIN THE SBT HOUSING. LACK OF THE SEAL CAUSED SIGNIFICANT AIR LEAK AROUND THE SCOPE THROUGHOUT THE PROCEDURE. THERE WAS ALSO SOME DIFFICULTY IN INFLATING THE STRUCTURAL BALLOON ATTACHED TO THE ACCESS PORT. A 5MM ADAPTOR WAS DEPLOYED AND 5MM SCOPE USED THROUGHOUT THE CASE. NO INJURY. SEX: UNKNOWN. PROCEDURE: LAP HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN OMS BALLOON BALLOON GCJ NORTH HAVEN - USS * U6H79

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN