BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1100623 · Received August 5, 2008

    Report

    Report Number
    MW5007909
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 7, 2008
    Report Date
    August 5, 2008
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING COLONOSCOPY PROCEDURE, AND DURING THE PROCEDURE, THE LIGATING DEVICE HANDLE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS POLYLOOP LIGATING DEVICE MND OLYMPUS AMERICA, INC. HX-400U-30 5K6157/59K

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR