BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 2864743 · Received November 9, 2012

    Report

    Report Number
    2647580-2012-00707
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 17, 2012
    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: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE BALLOON WAS BROKEN DURING PROCEDURE, BUT THE SAME TROUBLE OCCURRED. USING 3RD ONE, THE PROCEDURE WAS COMPLETED. NO BLEEDING. NO TISSUE DAMAGE. NOTHING FELL INTO CAVITY. NO PATIENT HARM. OPERATING ROOM TIME NOT EXTENDED BY MORE THAN 30 MINUTES. THE BALLOONS COULD HAVE BEEN DAMAGED BY MINI LOOP RETRACTOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1