BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBEROPTIC LIGHT CABLE

    MDR report key: 1517765 · Received October 16, 2009

    Report

    Report Number
    1418479-2009-00013
    Event Type
    Malfunction
    Date Received
    October 16, 2009
    Date of Event
    September 17, 2009
    Report Date
    October 16, 2009
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    EQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - 8061.456 - FIBEROPTIC LIGHT CABLE, 4.5MM - LOT#: 184O02. THE FIBEROPTIC LIGHT CABLE WAS CHECKED FOR LIGHT OUTPUT AND RESULTS WERE LOW LIGHT OUTPUT. THE ADAPTER ON THE CABLE WAS LOOSE AND THE RING WAS DISCOLORED. THERE WERE VISIBLE BROKEN FIBERS WITH BROWNISH COLOR. THE APPEARANCE OF THE CABLE SHOWS WEAR AND TEAR. THE CABLE HAS BEEN IN USE FOR APPROXIMATELY (7) SEVEN YEARS. THE CABLE WAS RETURNED TO THE CUSTOMER, PER THEIR REQUEST, AS IS. CAUSE: UNUSUAL, HOWEVER, WE BELIEVE THE BROKEN END FIBERS ALLOWED PROJECTED LIGHT TO SHINE THROUGH THE RUBBER INSULATION AND HEAT UP THE RUBBER MATERIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE FIBER LIGHT CABLE CAUSED A 1.000 INCH X .250 INCH BURN ON THE PATIENT'S ABDOMEN. THE APPEARANCE WAS OF A 'BUBBLE' WITHOUT REDNESS. ANTIBIOTIC OINTMENT WAS APPLIED TO THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBEROPTIC LIGHT CABLE FIBEROPTIC LIGHT CABLE EQH RICHARD WOLF MEDICAL INSTRUMENTS 8061.456 184O02

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR