BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 2890645 · Received November 21, 2012

    Report

    Report Number
    2647580-2012-00745
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTED AS: WHEN THE PORTS WERE INSERTED AND BALLOONS INFLATED, "A.FI", THEY BURST INSIDE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 10MM SPACEMAKER BLUNT GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P2G0820X

    Patients

    Seq Age Sex Outcome Treatment
    1