BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM PLUS SBT/OVAL BALLOON DISSECTOR

    MDR report key: 850604 · Received May 14, 2007

    Report

    Report Number
    1219930-2007-00252
    Event Type
    Injury
    Date Received
    May 14, 2007
    Date of Event
    April 26, 2007
    Report Date
    May 1, 2007
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP HERNIA REPAIR. REPORTEDLY, THE DISSECTOR BALLOON TWISTED WOULD NOT INFLATE NOR DEFLATE. THE SURGEON DECIDED TO CUT OFF THE BALLOON DISSECTOR TO USE STRUCTURAL BALLOON TROCAR. NOTHING FELL INTO THE SURGICAL CAVITY, HOWEVER, THE INCISION HAD TO BE EXTENDED TO CORRECT THE CONDITION. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM PLUS SBT/OVAL BALLOON DISSECTOR DISPOSABLE SURGICAL ACCESS DEVICE GCJ NORTH HAVEN - USS U7A46

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other