BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS GENERATOR

    MDR report key: 2110842 · Received June 2, 2011

    Report

    Report Number
    1643264-2011-00011
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 8, 2011
    Report Date
    May 2, 2011
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY OKLAHOMA CITY MANUFACTURE
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOUR TO FIVE MINUTES AFTER STARTING THE BURSECTOMY OF THE SUBACROMIAL SPACE, WITH THE WHIRLWIND PROBE, SURGEONS OBSERVED THE SKIN ALL SURROUNDING THE SITE TURNING TO WHITE AND AFTER THAT THEY SAW VAPOUR (SMOKE). THEY STOPPED, CHECKED THEY HAVE PLACED THE PROBE CORRECTLY INSIDE PATIENT'S BODY. DECIDED TO REPLACE THE PROBE AND FINISHED THE SURGERY WITH NO MORE PROBLEMS. WHIRLWIND WAS WASTED. AT THE BEGINNING THE BURNED AREAS WERE BLISTERS (FLICTENAS). BURNT OF 1ST, 2ND, AND 3RD DEGREE ARE CURRENTLY BEING HEALED BY PROFESSIONAL PLASTIC SURGERY DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS GENERATOR DYONICS RF GENERATOR GEI SMITH & NEPHEW ENDOSCOPY OKLAHOMA CITY MANUFACTURE 72202149

    Patients

    Seq Age Sex Outcome Treatment
    1