BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLALOCK PULMONIC CLAMP

    MDR report key: 1025963 · Received March 20, 2008

    Report

    Report Number
    1025963
    Event Type
    Malfunction
    Date Received
    March 20, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 20, 2008
    Manufacturer
    T. KOROS SURGICAL INSTRUMENTS CORP
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    BLALOCK CLAMP USED ON PORTAL VEIN BROKE DURING SVC ANASTOMOSIS. BROKE AT PORTAL VEIN SITE, RESULTING IN EXCESSIVE BLEEDING. BROKEN PIECES WERE RETRIEVED FROM ABDOMINAL CAVITY OF PATIENT. THE MANUFACTURER'S RESPONSE WAS THAT THE CLAMPS DID NOT MEET THEIR SPECIFICATIONS. THE MANUFACTURER RECOMMENDED NOT TO USE THE REMAINING CLAMPS AND IF NEEDED TO USE THEM GENTLY AND CAUTIOUSLY WITHOUT OVER TIGHTENING THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLALOCK PULMONIC CLAMP CLAMP, SURGICAL DXC T. KOROS SURGICAL INSTRUMENTS CORP SIZE 3 - 8-1/2 INCH LONG 97 L

    Patients

    Seq Age Sex Outcome Treatment
    1 *