BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2852124 · Received November 14, 2012

    Report

    Report Number
    2937094-2012-01197
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 24, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER TIP CRACKED AT 200 JOULES DURING A PROSTATE PROCEDURE. TWO ADDITIONAL FIBERS WERE REPORTED UNDER (REFERENCE MFR REPORT NUMBERS 2937094-2012-01243 AND 2937094-2012-01244); AT WHICH POINT THE PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE WITH ANOTHER FIBER. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 219H

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| GREENLIGHT HPS LASER SYSTEM