BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT

    MDR report key: 2442481 · Received January 20, 2012

    Report

    Report Number
    2937094-2012-00081
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 9, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER THAT ON (B)(6) 2012 THE CAP OF THE FIBER MELTED AND THE GLASS AT THE TOP OF THE FIBER CRACKED AT 160,123 JOULES. ADD'L INFO REPORTED BY THE CUSTOMER WAS THE BEAM WAS TESTED PRIOR TO USE INSIDE OF THE PT AND AT THE TIME OF THE TESTING THE BEAM WAS INTACT. THE BEAM WAS VISIBLE. DURING THE PROCEDURE, THE PT DID NOT EXPERIENCE ANY HARM FROM THE INCIDENT. THERE WERE NOT ERROR CODES THAT WERE DISPLAYED ON THE CONSOLE WHEN THE EVENT OCCURRED. THE USER DID NOT EXPERIENCER ANY INJURY FROM USE OF HE SYSTEM. A SECOND FIBER WAS USED AND THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER PROBLEMS. THE PT DID NOT HAVE ANY ISSUES POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED DELIVERY DEVICE, GREENLIGHT SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INC. 0010-2090 122H

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT SURGICAL LASER SYSTEM & ACCESSORIES