BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH XCEL BLUNT TIP TROCAR

    MDR report key: 1181137 · Received September 30, 2008

    Report

    Report Number
    3005075853-2008-01981
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP APPENDECTOMY PROCEDURE, AFTER INTRODUCING THE TROCAR, THEY FOUND THAT A BLOOD VESSEL HAD BEEN DAMAGED. CONSEQUENTLY THE PROCEDURE WAS CONVERTED TO OPEN TO CONTROL THE BLEEDING. THE PT LOST APPROXIMATELY 1100CC OF BLOOD AND HAD BLOOD PRODUCT ADMINISTERED POST-OP. THE AMOUNT OF BLOOD PRODUCT ADMINISTRATED IS UNK. THERE WAS NO ISSUE WITH INSERTION OF THE TROCAR. THE PT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLUNT TIP TROCAR GCJ ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention