BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICOUNTER SAFETY SPONGE SYSTEM

    MDR report key: 5034437 · Received August 27, 2015

    Report

    Report Number
    5034437
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 25, 2015
    Manufacturer
    STRYKER CORP
    Product Code
    LWH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING OR CHECK, SMELLED BURNING, NOTED UNIT CHARGE LIGHT AND DOCK LIGHT WERE NOT ON. WHEN EXAMINING SURGICOUNT SCANNER IT WAS NOTED TO HAVE A BURN MARK ON CONNECTION AREA (DOCKING SLOT) ALSO NOTED THE SAME BURN MARKS ON THE DOCKING UNIT/CRADLE ITSELF. UNIT AND DOCKING CRADLE REMOVED FROM THE OPERATING ROOM AND PLACED IN THE LEAD OFFICE. BACKUP UNIT PLACED IN OPERATING ROOM. UNIT MANUFACTURER WAS CALLED AT SURGICOUNT MEDICAL TO BE INFORMED OF EQUIPMENT MALFUNCTION AND HAZARD. MANUFACTURER RESPONSE FOR SURGICOUNT, SURGICOUNT MEDICAL (PER SITE REPORTER): SPOKE TO SURGITRACK REPRESENTATIVE ABOUT ETIOLOGY OF DEVICE DAMAGE EXPLORED. POSSIBLY DUE TO WATER CONDENSING IN PORT FROM CLEANING. INSERVICE TO RNS AND PERINATAL TECHS REGARDING CLEANING PROCEDURE. REQUESTED SURGITRACK R&D DEPT TO LOOK AT REDESIGN OF DOCKING PORTAL TO SIDE RATHER THAN AT BOTTOM OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566924 SURGICOUNTER SAFETY SPONGE SYSTEM COUNTER, SPONGE, SURGICAL LWH STRYKER CORP

    Patients

    Seq Age Sex Outcome Treatment
    1