BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE STRUCTURAL BALLOON TROCARS

    MDR report key: 1061164 · Received June 4, 2008

    Report

    Report Number
    1061164
    Event Type
    Malfunction
    Date Received
    June 4, 2008
    Date of Event
    May 20, 2008
    Report Date
    June 4, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE LAP HERNIA BALLOON DID NOT INFLATE ITS "WINGS" ON THE PEDIPORTS AND WOULD COLLAPSE INSTEAD OF STAY OPEN AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE STRUCTURAL BALLOON TROCARS TROCAR, BALLOON, HERNIA REPAIR GCJ COVIDIEN UNITED STATES SURGICAL CORPORATION OMST10SB P7H0928

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR