BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STORZ LIGHT CORD

    MDR report key: 1052314 · Received May 21, 2008

    Report

    Report Number
    2936485-2008-00044
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 7, 2008
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAS 3RD DEGREE BURN BECAUSE THE LIGHT SOURCE WAS LEFT LIT (FIBER OPTICS) ON TOP OF THE DRAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ LIGHT CORD LIGHT CORD FCW STRYKER ENDOSCOPY SAN JOSE 0233050064

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other