BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 3063717 · Received March 28, 2013

    Report

    Report Number
    2647580-2013-00163
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 1, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: BILATERAL INGUINAL HERNIA. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT THE BALLOON DECOMPRESSED CAUSING LEAK, THE PORT WAS SEATED PROPERLY. THE INCISION WAS NOT TOO LARGE THE PORT WAS REINFORCED AND THE PRESSURE IN THE PERITONEUM WAS MAINTAINED. PT INJURY: SUBCUTANEOUS EMPHYSEMA AND HYPERCARBIA, PT WAS ADMITTED TO ICU. SURGEON USED 2 DEVICES (FROM THE SAME LOT) DURING THIS SURGERY. THE 3RD ONE WORKING WITHOUT ANY FURTHER CONSEQUENCES. THERE WAS NO UNANTICIPATED TISSUE LOSS. 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
    127417 SPACEMAKER BLUNT TIP TROCAR 10MM SPACEMAKER BALLOONS GCJ COVIDIEN, FORMERLY USSC P2J0846X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other