BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 3080706 · Received April 9, 2013

    Report

    Report Number
    2647580-2013-00212
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP CHOLE. ACCORDING TO THE REPORTER: WHEN THE SURGEON WAS REMOVING THE GALLBLADDER, THE FOAM ADJUSTABLE COLLAR CAME OFF OF THE TROCAR. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144760 SPACEMAKER BLUNT TIP TROCAR 10MM SPACEMAKER BALLOONS GCJ COVIDIEN, FORMERLY USSC

    Patients

    Seq Age Sex Outcome Treatment
    1