BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVUTOME

    MDR report key: 6803290 · Received August 16, 2017

    Report

    Report Number
    MW5071662
    Event Type
    Malfunction
    Date Received
    August 16, 2017
    Date of Event
    August 15, 2017
    Report Date
    August 16, 2017
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS
    Product Code
    DWX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OLYMPUS VALVULOTOME BLADE WAS BROKE, CAUSING THE INSTRUMENT NOT TO WORKOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579406 VALVUTOME VALVUTOME DWX OLYMPUS MEDICAL SYSTEMS C-0103B / MD-738 71K

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR