BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF ASSURE CONSOLE MODEL 200X

    MDR report key: 6956755 · Received October 17, 2017

    Report

    Report Number
    3005883396-2017-05096
    Event Type
    Injury
    Date Received
    October 17, 2017
    Date of Event
    August 23, 2017
    Report Date
    November 8, 2017
    Manufacturer
    MITG - RF SURGICAL SYSTEMS
    Product Code
    LWH
    UDI-DI
    10884521700703
    PMA / PMN Number
    K062642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS PREVIOUSLY REPORTED TO THE FDA BY MEDTRONIC UNDER MEDWATCH FORM 3005883396-2017-05077. ADDITIONAL INFORMATION HAS BEEN RECEIVED, AND ALL FURTHER UPDATES FOR THIS ISSUE/DEVICE WILL NOW BE COMPLETED AS A FOLLOW-UP TO THIS NEW REPORT NUMBER. THE INCIDENT SAMPLE WAS REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE OR ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CONSOLE WAS RETURNED, AND AN EVALUATION OF THE SAMPLE COULD NOT CONFIRM THE ISSUE WITH FALSE POSITIVE DETECTIONS. A VISUAL INSPECTION FOUND NO DEFECTS. TESTING OF THE DEVICE IDENTIFIED NO ISSUES WITH DETECTING SPONGES AND NO FALSE DETECTIONS OCCURRED. THE INVESTIGATION FOUND THE DEVICE TO FUNCTIONED NORMALLY AS WELL AS WITHIN SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE WOULD GIVE A FALSE POSITIVE INDICATION THAT AN OBJECT WAS PRESENT WHEN THERE WAS NONE PRESENT. AN X-RAY WAS REQUIRED TO CONFIRM THAT A SPONGE WAS NOT PRESENT, AND THE X-RAY CAME BACK NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735581 RF ASSURE CONSOLE MODEL 200X COUNTER, SPONGE, SURGICAL LWH MITG - RF SURGICAL SYSTEMS 01-0043 10884521700703

    Patients

    Seq Age Sex Outcome Treatment
    1 Other