BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIX SHOOTER SAEED MUDLI-BAND LIGATOR

    MDR report key: 603801 · Received May 13, 2005

    Report

    Report Number
    1037905-2005-00054
    Event Type
    Malfunction
    Date Received
    May 13, 2005
    Date of Event
    April 13, 2005
    Report Date
    April 15, 2005
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN USED A WILSON-COOK SIX SHOOTER SAEED MULTI-BAND LIGATOR WITH AN ENDOSCOPE THAT HAS AN OUTER DIAMETER 9.0MM TO COMPLETE A VARICEAL LIGATION PROCEDURE. THE PT WAS DESCRIBED AS BEING COMBATIVE. UPON COMPLETION OF THE PROCEDURE AND REMOVED OF THE ENDOSCOPE, THE BARREL DETACHED IN THE PATIENT'S ESOPHAGUS. BECAUSE THE PT WAS COMBATIVE, THE BARREL WAS LEFT TO PASS NATURALLY. POST PROCEDURE, NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIX SHOOTER SAEED MUDLI-BAND LIGATOR UPGATORS MND WILSON-COOK MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN