BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFELOK

    MDR report key: 15057 · Received August 4, 1994

    Report

    Report Number
    MW1003026
    Event Type
    Injury
    Date Received
    August 4, 1994
    Date of Event
    July 20, 1994
    Report Date
    July 26, 1994
    Manufacturer
    PILLING CO.
    Product Code
    DXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CLAMP WAS PLACED ON THE SUPRA HEPATIC VENA CAVA. TAPE WAS TIED AROUND CLAMP TO RETRACT IT BACK AND THE JAW OF THE CLAMP BROKE OFF, LEAVING THE CUT VESSEL UNCLAMPED, CAUSING HEMORRHAGE. THIS CLAMP WAS BRAND NEW AND HAD ONLY BEEN USED ONCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFELOK VASCULAR CLAMP DXC PILLING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention