BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 2933398 · Received December 21, 2012

    Report

    Report Number
    2647580-2012-00807
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LADG- LAP ASSISTED DISTAL GASTRECTOMY. ACCORDING TO THE REPORTER: DURING PROCEDURE, THE BALLOON RUPTURED AND THE TROCAR CAME OFF THE INCISION. A NEW TROCAR WAS OPENED TO COMPLETE PROCEDURE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 12MM SPACEMAKER BALLOONS GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P2F0418X

    Patients

    Seq Age Sex Outcome Treatment
    1