BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS

    MDR report key: 1220911 · Received November 4, 2008

    Report

    Report Number
    MW5008872
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 22, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    LNK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING TRANSURETHRAL DESTRUCTION OF PROSTATE USING THE NIAGRA GREENLIGHT LASER, THE TIP OF THE LASER FIBER BROKE OFF INSIDE OF PT. DR. RECOVERED TIP OF FIBER BEFORE AWAKING PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS GREENLIGHT HPS BPH FIBER OPTIC (LASER) LNK AMERICAN MEDICAL SYSTEMS 10-2090-831D

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other