BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRANETICS EXCIMER LASER SYSTEM

    MDR report key: 3033067 · Received April 3, 2013

    Report

    Report Number
    1721279-2013-00037
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P910001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    LASER EVALUATION REPORT: UPON ARRIVAL, DAMAGE TO THE POWER CABLE CONNECTION CORD CONNECTING TO THE BACK OF THE UNIT WAS CONFIRMED. THE PLASTIC HOUSING HAD EXPOSING WIRES. THE FSE REPLACED THE POWER CABLE, POWER CONNECTOR RECEPTACLE, AND THE ANCHOR CONNECTION SPRING THAT SECURES THE POWER CORD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER PLUG WAS DAMAGED ON THE LASER SYSTEM. AN X-RAY TECH WAS CONNECTING THE POWER CORD TO THE LASER SYSTEM AND GOT SHOCKED WHEN PUSHING IN THE PLUG. NO MEDICAL ATTENTION WAS REQUIRED FOR THE X-RAY TECH, BUT HE DID RECEIVE A SMALL BURN MARK ON HIS FINGERS. THERE ARE EXPOSED WIRES ON THE POWER CORD AND THE LASER SYSTEM WILL NOT BE USED FOR THE CASE. THE PATIENT WAS TREATED BY OTHER MEANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136306 SPECTRANETICS EXCIMER LASER SYSTEM CVX-300 EXCIMER LASER MFA SPECTRANETICS CORPORATION CVX-300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other