BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBER LIGHT GUIDES

    MDR report key: 2422186 · Received January 19, 2012

    Report

    Report Number
    3003604053-2012-00002
    Event Type
    Injury
    Date Received
    January 19, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 21, 2011
    Manufacturer
    SMITH & NEPHEW ANDOVER MANUFACTURING SITE
    Product Code
    NBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT. THE EVALUATION SHOWED THE LIGHT SOURCE END OF THE LIGHT GUIDE HAD RETRACTED FIBERS. THIS IS CAUSED WHEN THE USER REMOVES THE LIGHT GUIDE FROM THE LIGHT SOURCE FROM THE BLUE SHEATHING. IT SHOULD BE REMOVED FROM THE ADAPTER. THE SCOPE END OF THE LIGHT GUIDE SHOWS NO DEFECTS. AS STATED IN THE COMPLAINT IT APPEARED THE USER REMOVED THE LIGHT GUIDE FROM THE SCOPE AND DRAPED THE LIGHT GUIDE ON THE PATIENT CREATING A BURN TO THE PATIENT'S THIGH. THERE IS NO DEFECT WITH THIS LIGHT GUIDE THAT CAUSED THE PATIENT BURN. THERE ARE PRECAUTIONS STATING HOW A PATIENT CAN BE BURNED IN OUR IFU 1060305. THIS COMPLAINT IS CAUSED BY THE USER. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    POST PROCEDURE IT IS NOTED THAT THE PATIENT HAD A SEVERE BURN ON THEIR INNER THIGH WHICH WAS THOUGHT TO BE CAUSED BY THE LIGHT LEAD. THE BURN WAS NOT NOTED INTRAOPERATIVELY. THE SURGICAL DRAPE HAD BEEN BURNED THROUGH TO THE PATIENT'S SKIN. IT HAS NOT BEEN CONFIRMED BUT IT WAS THOUGHT THE LIGHT LEAD HAD BEEN DISCONNECTED FROM THE ARTHROSCOPE FOR A PERIOD OF TIME AND THUS A BURN OCCURRING. HOSPITAL WANTED TO RULE OUT THE FACT THE LIGHT LEAD, VERSITIPS, AND LIGHT SOURCE WERE NOT FAULTY. THE 500XL WAS CHECKED AND IT SEEMS TO BE WORKING CORRECTLY. IT HAD ALSO BEEN USED THE DAY BEFORE FOR A NUMBER OF SCOPES AND NO PROBLEMS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBER LIGHT GUIDES LT GUIDE,GEMINI,5MM X 10FT NBH SMITH & NEPHEW ANDOVER MANUFACTURING SITE 7205178

    Patients

    Seq Age Sex Outcome Treatment
    1