BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSOLE, RF ASSURE MODEL 200E - E+ BOOST

    MDR report key: 6115069 · Received November 18, 2016

    Report

    Report Number
    3005883396-2016-00149
    Event Type
    Injury
    Date Received
    November 18, 2016
    Report Date
    November 2, 2016
    Manufacturer
    RF SURGICAL
    Product Code
    LWH
    PMA / PMN Number
    K062642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED FOR THE RF ASSURE CONSOLE 200E AND INDICATES THAT THIS SERIAL NUMBER WAS RELEASED MEETING ALL SPECIFICATIONS AS MANUFACTURED. THE LOT NUMBER OF THE CONCOMITANT BLAIR-PORT WAND WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RF ASSURE CONSOLE DETECTED AN RFID TAGGED SPONGE WHEN ONE WAS NOT PRESENT. ALL RFID TAGGED SPONGES WERE ACCOUNTED FOR. AN X-RAY WAS PERFORMED TO ENSURE A TAGGED SPONGE WAS NOT LEFT IN THE PATIENT. NO PATIENT INJURY OCCURRED. THE CUSTOMER STATED THAT THE CONSOLE WAS DETERMINED TO BE DEFECTIVE BECAUSE THERE HAD BEEN NO OTHER ISSUES WITH THE CONCOMITANT WAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762965 CONSOLE, RF ASSURE MODEL 200E - E+ BOOST SPONGE DETECTION SYSTEM LWH RF SURGICAL 01-0030

    Patients

    Seq Age Sex Outcome Treatment
    1 Other