BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAEED MULTI-BAND LIGATOR

    MDR report key: 4192847 · Received October 16, 2014

    Report

    Report Number
    MW5038704
    Event Type
    Injury
    Date Received
    October 16, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    COOK MEDICAL
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ESOPHAGEAL VARICES BANDING PERFORMED BY GI PHYSICIAN. SIX SHOOTER TIP CAME OFF WHILE SCOPE IN ESOPHAGUS, HAD TO RESCOPE PT WHILE STILL IN PROCEDURE ROOM TO RETRIEVE TIP. EQUIPMENT MALFUNCTION. COOK T SHOOTER, REF# MBL-U-6, G31917M LOT# W3406773. EXP 3/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658961 SAEED MULTI-BAND LIGATOR COOK T SHOOTER MND COOK MEDICAL MBL-U-6 W3406773

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention