BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1844193 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00245
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    April 15, 2010
    Report Date
    July 9, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS - INNOVATION CTR - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER CAP DETACHED AT 6,186 JOULES. NO PT INJURY OCCURRED. A DEVICE EVAL IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS - INNOVATION CTR - SILICON VALLEY NA 002H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other