BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTIBAND LIGATOR

    MDR report key: 528861 · Received May 13, 2004

    Report

    Report Number
    528861
    Event Type
    Other
    Date Received
    May 13, 2004
    Date of Event
    April 1, 2004
    Report Date
    May 1, 2004
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 7/30/2004: DEVICE FAILURE RELATED TO USER HANDLING. EXPLANATION: THE INFO PROVIDED WITH THIS REPORT INDICATED THE ENDOSCOPE USED WITH THIS DEVICE HAS AN OUTER DIAMETER OF 8.6 MM. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT INSTRUCT THE USER TO REFER TO THE PRODUCT PACKAGE LABEL FOR USE OF THE APPROPRIATE ENDOSCOPE. THE PRODUCT PACKAGE LABEL STATES THAT THE MBL-6 IS COMPATIBLE WITH ENDOSCOPES THAT HAVE AN OUTER DIAMETER OF 9.5 MM - 13 MM. WE BELIEVE THAT THE BARREL DETACHMENT OBSERVED BY THE USER OCCURRED BECAUSE THE DEVICE WAS USED WITH INCOMPATIBLE EQUIPMENT. THE INITIAL REPORTER INDICATED THE PRODUCT WOULD NOT BE RELEASED FROM THEIR FACILITY FOR EVALUATION.

    Description of Event or Problem · 1

    SIX SHOOTER BANDING DEVICE (MULTIBAND LIGATOR) USED PER INSTRUCTIONS FOR ESOPHAGEAL VARICES BANDING. WHEN PROCEDURE COMPLETED, SCOPE WITHDRAWN WITH PLASTIC CAP FROM SHOOTER NOT COMING BACK WITH SCOPE, BUT STAYED IN ESOPHAGUS. PLASTIC DEVICE RETRIEVED WITH RAT TOOTH FORCEPS. STRING DID NOT HOLD PLASTIC DEVICE UNTIL RETRIEVED AS IT SHOULD HAVE. CAP POSSIBLY NOT PUSHED FAR ENOUGH ON SCOPE, BUT IT SHOULD HAVE STAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIBAND LIGATOR 6 SHOOTER BANDING DEVICE MND WILSON-COOK MEDICAL, INC. MBL6 W1775509

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other