BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM X 10FT FIBEROPTIC LIGHTCABLE

    MDR report key: 2211408 · Received August 8, 2011

    Report

    Report Number
    2936485-2011-00552
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 23, 2009
    Report Date
    July 12, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FST
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED FAILURE COULD NOT BE CONFIRMED. PAST COMPLAINTS INVOLVING A SIMILAR PRODUCT AND FAILURE MODE HAVE BEEN PRIMARILY CAUSED BY USER ERROR. THE IFU FOR THE PRODUCT CAUTIONS AGAINST LEAVING THE ADAPTER ATTACHED TO THE LIGHTCABLE WITHOUT A SCOPE ATTACHED. IF THIS OCCURS, THE LIGHTSOURCE WILL CONTINUE TO GENERATE HEAT WHICH IN TURN COULD CAUSE BURNS OR FIRES IF ALLOWED TO COME INTO CONTACT WITH DRAPES, CLOTH, OR PAPER. IN THIS PARTICULAR COMPLAINT, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE SINCE THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. IN SUM, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SHOULDER SURGERY, THE UNIT CAUSED A LARGE SERPENTINE THIRD DEGREE BURN UNDER THE RIGHT ARM OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM X 10FT FIBEROPTIC LIGHTCABLE LIGHTCABLE FST STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other