BEUDAMED
    FDA Adverse Event Other Summary report: N

    RF ASSURE DETECTION SYSTEM

    MDR report key: 3652882 · Received January 28, 2014

    Report

    Report Number
    3005883396-2014-00001
    Event Type
    Other
    Date Received
    January 28, 2014
    Date of Event
    August 26, 2013
    Report Date
    January 24, 2014
    Manufacturer
    RF SURGICAL SYSTEMS INC.
    Product Code
    LWH
    PMA / PMN Number
    K062642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY DID NOT REPORT AN ADVERSE EVENT OR ANY PT RELATED INCIDENT TO RF SURGICAL SYSTEMS, BUT THE HOSPITAL OPERATING ROOM MANAGER REQUESTED A SCAN RECORD FOR A SPECIFIED DATE, ON (B)(6) 2013, FROM A SPECIFIC RF ASSURE CONSOLE IN THE HOSPITAL'S POSSESSION. AT THE HOSPITAL'S REQUEST, RF SURGICAL SYSTEMS (RFS) ENGINEERS DETERMINED FROM THE STORED DATA IN THE DETECTION CONSOLE, THAT THE CONSOLE WAS FUNCTIONING PROPERLY ON THE DATE IN QUESTION, AS TWO SCANS WERE RECORDED INCLUDING ONE SCAN WITH A TYPICAL INDICATION OF THE PRESENCE OF AN RF TAGGED SPONGE. THE LOG ALSO SHOWED A 2ND SCAN PERIOD OF 2 SECONDS WHICH DID NOT MEET THE STATED SCANNING PROCEDURE IN THE RF ASSURE DIRECTIONS FOR USE (DFU). A FOLLOW UP VISIT BY AN RFS REPRESENTATIVE IN EARLY (B)(4) 2013 CONFIRMED THAT THE HOSPITAL-DESIGNATED RF ASSURE CONSOLE FROM WHICH THE DATA WAS RETRIEVED WAS FUNCTIONING PROPERLY. AS OF THE DATE OF THIS REPORT, THE RF ASSURE CONSOLE IN QUESTION HAS NOT BEEN RETURNED FOR ANALYSIS OR THE REPORTED ISSUES. FURTHER, NO RESPONSE WAS RECEIVED FROM THE HOSPITAL OPERATING ROOM MANAGER AFTER REPEATED REQUESTS INFO RELATED TO HER SCAN DATA REQUEST. LASTLY, RECENT ATTEMPTS TO CONTACT THE OPERATING ROOM MANAGER FOR INFO FOLLOWING THE MAUDE REPORT HAVE YIELDED NO RESPONSE. RF SURGICAL'S INVESTIGATION CONCLUDES THAT THE RF ASSURE SYSTEM FUNCTIONED PROPERLY, AND WE ATTRIBUTE THE INCIDENT TO A DEVIATION FROM OPERATING PROTOCOL. SHOULD ADDITIONAL PERTINENT INFO BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(4). PLEASE NOTE THAT THE EVENT RELATED TO THE MDR WAS NOT REPORTED BY THE USER FACILITY TO THE MFR. RF SURGICAL SYSTEMS BECAME AWARE OF THE INCIDENT ON (B)(6) 2014 AS PUBLISHED VIA THE FDA MAUDE DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60317 RF ASSURE DETECTION SYSTEM RF ASSURE DETECTION SYSTEM LWH RF SURGICAL SYSTEMS INC. 200 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention