BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLALOCK CLAMP

    MDR report key: 1032566 · Received March 25, 2008

    Report

    Report Number
    1032566
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    March 23, 2008
    Report Date
    March 25, 2008
    Manufacturer
    T. KOROS SURGICAL INSTRUMENTS CORP.
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING AN ORTHOTOPIC LIVER TRANSPLANT, PATIENT WAS ON VENO-VENOUS BYPASS. DURING THE HEPATECTOMY, EXCESSIVE BLEEDING WAS NOTED BY THE SURGEON; ANESTHESIA MENTIONED THE BLOOD PRESSURE WAS DROPPING. CHECKED THE BLALOCK CLAMP ON THE INFRAHEPATIC VENA CAVA AND FOUND THE CLAMP HAD BROKEN IN TWO PIECES. 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 CLAMP CLAMP, INSTRUMENT HXD T. KOROS SURGICAL INSTRUMENTS CORP. * 97L

    Patients

    Seq Age Sex Outcome Treatment
    1 *