BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2934445 · Received January 11, 2013

    Report

    Report Number
    2937094-2013-00026
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    January 19, 2012
    Report Date
    April 23, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A CLINICAL STUDY PATIENT HAD A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE ON (B)(6) 2012. REPORTEDLY, THERE WAS A "RUPTURE OF HEAD OF THE MOXY FIBER", A SECOND FIBER (0010-2090-043H-2213) WAS USED IN THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19287 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 126A

    Patients

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