BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF SCANNER DETECTION SYSTEM

    MDR report key: 1753954 · Received June 17, 2010

    Report

    Report Number
    1753954
    Event Type
    Malfunction
    Date Received
    June 17, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 17, 2010
    Manufacturer
    RF SURGICAL SYSTEMS
    Product Code
    LWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TEST SCAN USING THE RF SCAN MACHINE OVER THE DELIVERY TABLE DID NOT DETECT THE BLOOD SATURATED SPONGES. IT DID DETECT THE CLEAN, DRY SPONGE. THE WAND DETECTED A BLOODY SPONGE WHEN IT WAS HELD HORIZONTALLY OVER THE SPONGE; HOWEVER, IT DID NOT DETECT THE SPONGE WHEN IT WAS HELD AT AN ANGLE. THE PROBLEM SEEMED TO BE TECHNIQUE DEPENDENT. AT CERTAIN ANGLES, IT WOULD DETECT WET SPONGES, BUT NOT AT OTHER ANGLES. THE USER WAS EXPERIENCED. ANOTHER WAND WAS UTILIZED AND THE SAME PROBLEM WAS EXPERIENCED. THE WANDS WERE NOT SAVED.====================== MANUFACTURER RESPONSE FOR RF SCANNER, RF SCANNER DETECTION SYSTEM======================EXCHANGED OUT THE MACHINE TO TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF SCANNER DETECTION SYSTEM RF SCANNER LWH RF SURGICAL SYSTEMS 5.1 MODEL 100A *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR