BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 3063465 · Received March 28, 2013

    Report

    Report Number
    2647580-2013-00153
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 27, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: TEP TOTALLY EXTRA PERITONEAL. ACCORDING TO THE REPORTER: DURING PLACING AND FIXING OF THE BLUNT-TIP TROCAR THE WHITE FORM MATERIAL OF THE CUFF IS FALLEN IN THE BELLY SPACE OF THE PT AND HAD TO BE RETRIEVED. THE INCIDENT WAS NOTICED BY THE SURGEON IMMEDIATELY AND THE MATERIAL WAS REMOVED. ANOTHER BLUNT-TIP TROCAR WAS USED. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127356 SPACEMAKER BLUNT TIP TROCAR 10MM SPACEMAKER BALLOONS GCJ COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P2J0401X

    Patients

    Seq Age Sex Outcome Treatment
    1