BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT PV ADDSTAT

    MDR report key: 2209317 · Received August 2, 2011

    Report

    Report Number
    2937094-2011-01569
    Event Type
    Malfunction
    Date Received
    August 2, 2011
    Date of Event
    March 15, 2006
    Report Date
    June 29, 2011
    Manufacturer
    AMS INNOVATION CENTER - SILICONE VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K010284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO RECEIVED INDICATED AN MDR WAS REQUIRED ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2006, THE AIMING BEAM FIRED STRAIGHT OUT OF THE FIBER AT 161, 582 JOULES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT PV ADDSTAT SURGICAL FIBER GEX AMS INNOVATION CENTER - SILICONE VALLEY NA 545D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other