BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS GENERATOR

    MDR report key: 1911969 · Received December 1, 2010

    Report

    Report Number
    1643264-2010-00016
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 1, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY OKLAHOMA CITY MANUFACTURE
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH 21 CFR 803, THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY DIV WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. PRODUCT WAS NOT RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    PATIENT EXPERIENCED 2ND DEGREE BURNS DURING SHOULDER SURGERY. SETTINGS USED WERE 7 WHICH IS THE DEFAULT. USING WHIRLWIND WAND. SALES REP STATED THAT THE BURNS CAME FROM THE FLUID DRIPPING FROM THE CANNULA AND RUNNING DOWN THE PATIENT'S SHOULDER. THE STAFF JUST LETS THE FLUID DRIP FROM THE CANNULA RATHER THAN HOOKING UP TUBING AND DRIPPING INTO A BAG. THE WARNINGS SECTION OF THE PROBE IFU STATES THAT ENSURE ADEQUATE FLOW AND CIRCULATION OF SALINE TO PREVENT UNNECESSARY HEATING OF THE SOLUTION THAT MAY RESULT IN TISSUE DAMAGE.

    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 D01946

    Patients

    Seq Age Sex Outcome Treatment
    1