BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MW5085612

    MDR report key: 8487318 · Received April 4, 2019

    Report

    Report Number
    MW5085612
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 29, 2019
    Report Date
    April 2, 2019
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING GREENLIGHT LASER PROSTATECTOMY, AS DEVICE WAS BEING UTILIZED PER MFR'S INSTRUCTIONS, THE AMERICAN MEDICAL SYSTEM (AMS) GREENLIGHT MOXY FIBER OPTIC TIP HAD SEPARATED FROM THE LASER FIBER. THE TIP WAS RECOVERED IN ITS ENTIRETY. FDA SAFETY REPORT ID# (B)(4).

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR