BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X7000 XENON LIGHTSOURCE

    MDR report key: 2833022 · Received November 1, 2012

    Report

    Report Number
    2936485-2012-00536
    Event Type
    Injury
    Date Received
    November 1, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 8, 2012
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FSS
    PMA / PMN Number
    K961971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT OVER HEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X7000 XENON LIGHTSOURCE FSS STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK