BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1833392 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00408
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010 A HOLE WAS FOUND ON THE FIBER OPTIC BY THE PHYSICIAN. THE PHYSICIAN DID NOT WANT TO TAKE ANY CHANCES AND USED THE FIBER UNTIL 12,848 JOULES. NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY NA 011H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other