BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANBERG LASER APPLICATOR

    MDR report key: 14741343 · Received June 19, 2022

    Report

    Report Number
    3012452798-2022-00001
    Event Type
    Malfunction
    Date Received
    June 19, 2022
    Date of Event
    April 29, 2022
    Report Date
    April 29, 2022
    Manufacturer
    CLINICAL LASERTHERMIA SYSTEMS AB
    Product Code
    GEX
    PMA / PMN Number
    K201466
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHYSICIAN HAD PLANNED FOR 2X 15 MM DIFFUSER LASER APPLICATORS FOR A HUGE VASCULAR MALFORMATION PROCEDURE. BOTH LASER FIBERS WERE UNPACKED ON THE STERILE TRAY. THE FIBERS ARE 12M LONG. FOR ALL MR-GUIDED PROCEDURES, THE LASER UNIT IS LOCATED OUTSIDE OF THE MR SUITE, AT THIS SITE, IN THE TECHNIQUE ROOM. THE FIBER END WITH THE SMA CONNECTOR GOES FROM THE STERILE AREA VIA THE WAVEGUIDE TO THE LASER UNIT FOR CONNECTION. THE ITEM IN QUESTION HAS BEEN HANDLED AS USUAL AND WAS CARRIED THROUGH THE WAVEGUIDE AND CONNECTED TO THE LASER UNIT. BETWEEN THE WAVEGUIDE AND THE LASER UNIT ONE OR MORE SLINGS OF THE FIBER WERE FREE HANGING TO THE FLOOR. THE TREATMENT STARTED WITH 15W AND AFTER 48S THE PHYSICIAN WAS SMELLING BURNT PLASTIC AND SHUT THE LASER IMMEDIATELY OFF. APPROXIMATELY 12 INCHES (~ 30CM) FROM THE SMA CONNECTOR THE FIBER WAS BURNING AND MELTING WITH A SMALL FLAME. LUCKILY HE COULD DIRECTLY PUT THE FLAME OUT. THE REST OF THE FIBER SEEMS UNAFFECTEDLY. HE CAREFULLY REMOVED THE FIBER FROM THE PATIENT. THERE WAS NOTHING RELATED TO THE FIBER TIP END (> 11 M AWAY). NO HARM TO THE PATIENT OR CLINICAL STAFF OR OTHERS. THE PHYSICIAN CONTINUED THE TREATMENT WITH THE SECOND FIBER, CONNECTED TO THE CLS LASER UNIT AND IT WENT AS IT SHOULD. HE COULD TREAT AND FINALIZE HIS 3 H PROCEDURE WITH THIS SECOND FIBER. THE BURNED FIBER WAS KEPT AND WILL BE SHIPPED TO THE MANUFACTURER. THE TREATMENT LOG FILES FROM THE LASER UNIT WERE REQUESTED AND WERE SENT IN THE EVENING. THEY ARE SENT TO R&D AND QM/RA. WHILE COLLECTING DATA FROM THE EVENT, CLS INITIATED THE REGISTRATION PROCESS TO COMPLY WITH THE ELECTRONIC REQUIREMENTS FOR EMDR'S. THE TIME TO UPDATE FILES AND ESTABLISH EMDR EXCEEDED EXPECTATIONS AND RESULTED IN THE FILING OF THE REPORT TO EXCEED BY 16 DAYS THE REQUIREMENTS FOR REPORTING.

    Description of Event or Problem · 0

    KINK IN LINE RESULTED IN OVERHEATING AND MELTING OF LINE. LINE WAS REPLACED WITH NO ADVERSE EVENT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813216 TRANBERG LASER APPLICATOR LASER APPLICATOR GEX CLINICAL LASERTHERMIA SYSTEMS AB 4017-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention