BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER X6000 XENON LIGHTSOURCE

    MDR report key: 371300 · Received January 7, 2002

    Report

    Report Number
    2936485-2001-00047
    Event Type
    Other
    Date Received
    January 7, 2002
    Date of Event
    December 11, 2001
    Report Date
    January 4, 2002
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT DURING A CASE, THE PATIENT RECEIVED A BURN AROUND THE UMBILICAL PORT. THE EQUIPMENT BEING USED WAS A STRYKER CAMERA AND LIGHTSOURCE WITH LIGHTSOURCE TUBING FROM LEXION AND A SCOPE FROM WOLFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER X6000 XENON LIGHTSOURCE LIGHTSOURCE GCT STRYKER ENDOSCOPY 0220-185-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other