BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-7000 LIGHTSOURCE

    MDR report key: 683968 · Received March 2, 2006

    Report

    Report Number
    2936485-2006-00015
    Event Type
    Malfunction
    Date Received
    March 2, 2006
    Date of Event
    February 1, 2006
    Report Date
    February 1, 2006
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    FFS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE LIGHTSOURCE ACTIVATED ITSELF OFF OF STANDBY. THE LIGHTCORD WAS NOT CONNECTED TO A SCOPE AND BURNT THE DRAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-7000 LIGHTSOURCE LIGHTSOURCE FFS STRYKER ENDOSCOPY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN