BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 3080694 · Received April 9, 2013

    Report

    Report Number
    2647580-2013-00193
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: NEPHRECTOMY. ACCORDING TO THE REPORTER: THE BALLOON RUPTURED DURING PROCEDURE. THE BALLOON WAS INJECTED WITH MORE THAN 25ML OF AIR (APPROX. 28 ML). FALLEN PIECES WERE RETRIEVED FROM THE CAVITY. NEW DEVICE WAS OPENED TO COMPLETE PROCEDURE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147910 SPACEMAKER BLUNT TIP TROCAR 12MM SPACEMAKER BALLOONS GCJ COVIDIEN, FORMERLY USSC

    Patients

    Seq Age Sex Outcome Treatment
    1