BEUDAMED
    FDA Adverse Event Summary report: N

    BLAIR-PORT

    MDR report key: 4173653 · Received August 18, 2014

    Report

    Report Number
    4173653
    Date Received
    August 18, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 18, 2014
    Manufacturer
    RF SURGICAL SYSTEMS INC.
    Product Code
    LWH
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    SURGICAL NURSES EXPRESSED CONCERN THAT THEY COULD MISS DETECTING A SURGICAL SPONGE LEFT WITHIN A PATIENT'S SURGICAL SITE AS A RESULT OF CONFUSION CAUSED BY A DIFFERENCE IN THE TWO MODES OF OPERATION OF THE SPONGE DETECTION SYSTEM. NURSING STAFF ASSUMED THAT THE WAND DETECTION SYSTEM WOULD CONTINUE TO INDICATE THAT A SPONGE HAD BEEN DETECTED, UNTIL THE ALERT IS ACKNOWLEDGED ON THE CONSOLE TOUCH SCREEN, AS THE PAD DETECTION MODE DOES. INSTEAD THE WAND DETECTED SPONGE ONLY CREATES AN ALERT WHILE THE WAND IS IN THE PROXIMITY OF THE SPONGE, AND THEN CLEARS THE INDICATION AS SOON AS THE WAND IS MOVED AWAY. THE DIRECTIONS FOR USE DO NOT INDICATE THE DIFFERENCE IN OPERATION OF THE TWO MODES.======================MANUFACTURER RESPONSE FOR SPONGE DETECTION SYSTEM, RF ASSURE (PER SITE REPORTER).======================

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494825 BLAIR-PORT COUNTER, SPONGE, SURGICAL LWH RF SURGICAL SYSTEMS INC. * *
    495020 RF SURGICAL DETECTION SYSTEM COUNTER, SPONGE, SURGICAL LWH RF SURGICAL SYSTEMS INC. 200E *

    Patients

    Seq Age Sex Outcome Treatment
    1 *