BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER PERIPHERALS

    MDR report key: 5338058 · Received December 1, 2015

    Report

    Report Number
    1221543-2015-00002
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Date of Event
    November 5, 2015
    Report Date
    November 30, 2015
    Manufacturer
    LASER PERIPHERALS
    Product Code
    GEX
    PMA / PMN Number
    K030959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RMA #(B)(4). PROBABLE CAUSE IS HANDLING, STRESS DURING SCOPE INSERTION OR COMBINATION OF BOTH.

    Description of Event or Problem · 1

    SECOND DEGREE BURN ON THE PATIENT'S UPPER THIGH/GROIN AREA. HOSPITAL IS UNSURE WHEN IT OCCURRED DURING THE PROCEDURE, IT WAS NOTICED AFTER THE CASE WAS COMPLETED. THE PROCEDURE WAS LFD, DTA'S, WITH DISCECTOMY, LAMINOTOMY FORAMINOTOMY DECOMPRESSION OF THE NERVE ROOT, DESTRUCTION VIA THERMAL ABLATION OF THE PARAVERTEBRAL FACET JOINT. NO SECOND PROCEDURE WAS REQUIRED, OINTMENT AND A BANDAGE WAS USED, PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790477 LASER PERIPHERALS SURGICAL LASER FIBER GEX LASER PERIPHERALS RBLF-1000-PL H1550 (LP-869)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention