BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2031213 · Received March 16, 2011

    Report

    Report Number
    2937094-2011-00445
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    August 23, 2010
    Report Date
    November 29, 2010
    Manufacturer
    AMS INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO REGARDING THIS COMPLAINT WHICH INDICATED THAT AN MDR WAS REQUIRED, WAS RECEIVED ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2010 THE FIBER CAP DETACHED AT 170,000 JOULES. ALSO, IT WAS REPORTED THAT THE FIBER CAP WAS RETRIEVED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS INNOVATION CENTER - SILICON VALLEY NA 001L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other