BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 2933399 · Received December 21, 2012

    Report

    Report Number
    2647580-2012-00808
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 30, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LEFT HEPATECTOMY. ACCORDING TO THE REPORTER: AFTER 2 HOURS THE BALLOON BURST WITH A VERY LOUD NOISE. NO ILL EFFECT TO THE PATIENT, AS THE BALLOON DIDN'T BREAK IN PIECES, BUT RATHER A SPLIT. THE SURGEON REMOVED THE TROCAR AND USED A SECOND ONE. NO ILL EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 12MM SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P2G0371X

    Patients

    Seq Age Sex Outcome Treatment
    1