BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.3MM DISPOSABLE ANGIOSCOPE

    MDR report key: 3289327 · Received August 12, 2013

    Report

    Report Number
    MW5031421
    Event Type
    Malfunction
    Date Received
    August 12, 2013
    Date of Event
    August 9, 2013
    Report Date
    August 9, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    LYK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    APPLIED MEDICAL 2.3MM DISPOSABLE ANGIOSCOPE WOULD NOT DISPLAY PICTURE DURING SURGICAL PROCEDURE. REPLACED WITH IDENTICAL SCOPE WHICH WORKED FINE. REASON FOR USE: LEFT FEM-POP BYPASS WITH INSERTION OF SAPHENOUS VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385939 2.3MM DISPOSABLE ANGIOSCOPE LYK APPLIED MEDICAL ANG-080-D10K 1174936

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR