BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAXCESS LIGHT CABLE GUIDE

    MDR report key: 3982613 · Received July 17, 2014

    Report

    Report Number
    2031966-2014-00047
    Event Type
    Other
    Date Received
    July 17, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 17, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    FST
    PMA / PMN Number
    K042034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHOTO CONFIRMED THE REPORTED EVENT. AFTER THE PATIENT WAS TREATED WITH SILVADENE OINTMENT AND THERE HAS BEEN NO REPORT OF INFECTION OR DETERIORATION OF THE PATIENT'S HEALTH. THERE WAS NO ALLEGED MALFUNCTION OF THE DISPOSABLE LIGHT CABLE AND THE LIGHT CABLE WAS INADVERTENTLY DISCARDED BY HOSPITAL DUE TO ITS SINGLE USE NATURE. IT IS UNKNOWN HOW THE LIGHT CABLE DISCONNECTED FROM THE RETRACTOR. THE DEVICE WAS NOT RETURNED AND COULD NOT BE INVESTIGATED FURTHER. NO OTHER EVENTS OF THIS NATURE HAVE BEEN REPORTED IN THE LAST FOUR YEARS. THE CAUSE OF THE ISSUE WAS THE ACCIDENTAL DISCONNECTION OF THE LIGHT CABLE FROM ITS INTENDED RETRACTOR ATTACHMENT POSITION. THIS IS AN ISOLATED INCIDENT. THE HEAT GENERATED FROM THE LIGHT CABLE IS A KNOWN CHARACTERISTIC OF FIBER OPTIC LIGHT CABLES AND CARE SHOULD BE TAKEN TO ENSURE PROPER PLACEMENT IN THE SURGICAL SITE AND RETENTION WITHIN THE RETRACTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLIF SPINAL SURGERY, THE STERILE LIGHT CABLE FELL OUT OF THE RETRACTOR AND OUT OF THE SURGICAL SITE, AND CAME IN CONTACT WITH THE DRAPE AND THE PATIENT'S SKIN. THE DURATION OF THE ACCIDENTAL DISCONNECTION FROM THE RETRACTOR IS UNKNOWN. WHEN NOTICED, THE LIGHT CABLE WAS REMOVED FROM THE PATIENT AND A DIME SIZE (OR SMALLER) VESICATION WAS EVIDENT. THE MINOR INJURY WAS NOTED TO HAVE REDNESS, SWELLING AND SMALL BLISTERING THAT WAS TREATED WITH SILVADENE OINTMENT AT THE TIME OF THE EVENT. NO ADDITIONAL TREATMENT OR INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420535 MAXCESS LIGHT CABLE GUIDE LIGHT, SURGICAL, FIBEROPTIC FST NUVASIVE, INC. 3400044 LS0261

    Patients

    Seq Age Sex Outcome Treatment
    1