BEUDAMED
    FDA Adverse Event Other Summary report: N

    PILLING HEAD LAMP CABLE

    MDR report key: 1202786 · Received October 16, 2008

    Report

    Report Number
    1044475-2008-00035
    Event Type
    Other
    Date Received
    October 16, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 25, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EBA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: NO HOLE WAS FOUND IN THE CABLE. INTERNAL FIBER BREAKAGE WITH NO POSSIBILITY OF SURGEON BURNING BACK. INTERNAL FIBER BREAKAGE. CONCLUSION: ACULUX, THE MANUFACTURER, STATES THAT CAUSE OF BREAKAGE COULD BE DUE TO THE CABLE WAS COILED IMPROPERLY OR ROLLED OVER WITH CART/FLOORSTAND.

    Description of Event or Problem · 1

    THE COMPLAINT DESCRIPTION WAS REPORTED AS: THE SURGEON WAS USING THE HEADSET AND CABLE WHEN HE FELT A BURNING SENSATION ON HIS BACK. THE CIRCULATING NURSE LOOKED AT HIS BACK AND SAW THAT THERE WAS A HOLE IN THE CABLE, AND LIGHT WAS COMING THROUGH THIS HOLE AND BURNING THE SURGEON'S BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING HEAD LAMP CABLE HEAD LAMP CABLE EBA TELEFLEX MEDICAL NA 5072-41

    Patients

    Seq Age Sex Outcome Treatment
    1