BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS-HPS FIBEROPTICS-BPH FIBEROPTIC GREEN LIGHT HPS

    MDR report key: 1404737 · Received June 18, 2009

    Report

    Report Number
    MW5011587
    Event Type
    Injury
    Date Received
    June 18, 2009
    Date of Event
    June 16, 2009
    Report Date
    June 18, 2009
    Product Code
    OEL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING GREENLIGHT PROCEDURE, THE TIP BROKE OFF OF THE FIBER INSIDE THE PATIENT BLADDER. SURGEON WAS ABLE TO RETRIEVE BROKEN OFF TIP. X-RAYS TAKEN TO ENSURE NO OTHER PIECE WAS IN BLADDER AND NONE WAS FOUND. DIAGNOSIS OR REASON FOR USE: OBSTRUCTIVE LOWER URINARY TRACT SYMPTOMS STATUS POST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS-HPS FIBEROPTICS-BPH FIBEROPTIC GREEN LIGHT HPS NONE OEL 10-2090 10-2090-910W

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability