BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM PLUS SBT/ROUND BALLOON DISSECTOR

    MDR report key: 872002 · Received June 26, 2007

    Report

    Report Number
    1219930-2007-00333
    Event Type
    Injury
    Date Received
    June 26, 2007
    Date of Event
    June 19, 2007
    Report Date
    June 19, 2007
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER, THE SURGEON TRIED TO INFLATE DISSECTION BALLOON AND AIR WAS LEAKING THROUGH THE SEAL AROUND THE 10MM SCOPE. SURGEON HOWEVER WAS ABLE TO GET A VISUAL AND DETERMINED HE WAS IN THE INTRAPERITONEAL SPACE INSTEAD OF EXTRAPERITONEAL - TEPP, HE SUBSEQUENTLY DECIDED TO CONVERT TO OPEN APPROACH. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM PLUS SBT/ROUND BALLOON DISSECTOR DISPOSABLE SURGICAL STAPLER GDI NORTH HAVEN - USS U6L14

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O