BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCOUNT SYSTEM

    MDR report key: 3214877 · Received July 2, 2013

    Report

    Report Number
    3214877
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    CLEARCOUNT MEDICAL SOLUTIONS INC
    Product Code
    LWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE RN CIRCULATOR AND SURGICAL TECH COMPLETED A MANUAL COUNT OF 45 LAPAROTOMY SPONGES PER HOSP POLICY AND WERE PLACED IN THE CLEARCOUNT RECEPTACLE. CLEARCOUNT READ 44 LAPAROTOMY SPONGES. THE PT WAS 'WANDED' AND A SPONGE WAS DETECTED. THE SURGICAL INCISION WAS EXTENDED AND THE WOUND EXPLORED. A RFID 'CHIP' WAS FOUND IN THE SURGICAL WOUND. A PACKAGE OF SAME SIZE SPONGES 18 IN X 18 IN [45.72 CM X 45.72 CM] SMARTSPONG LAP SPONGE REF (B)(4), LOT: HQ450 62659 45 AS WERE USED IN THE CASE (BUT MAY NOT BE THE SAME LOT NUMBER AS THE INVOLVED SPONGE) WAS OPENED AND INSPECTED. THE RFID CHIP 'POCKET' WAS SPLIT WHICH ALLOWS FOR CHIP TO EASILY FALL INTO WOUND AS OCCURRED IN THE CASE BEING REPORTED. MACHINE SERIAL # (B)(4). (B)(4). THE LAPAROTOMY SPONGE USED IN THE CASE AND THE RFID 'CHIP' RETRIEVED FROM THE SURGICAL WOUND ARE NOT AVAILABLE FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300492 CLEARCOUNT SYSTEM NONE LWH CLEARCOUNT MEDICAL SOLUTIONS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other