BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARCOUNT

    MDR report key: 3008152 · Received March 15, 2013

    Report

    Report Number
    3008152
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    April 17, 2012
    Report Date
    March 15, 2013
    Manufacturer
    CLEARCOUNT MEDICAL SOLUTIONS, INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELEVEN SEPARATE EVENTS TOTAL WITH RFID 4X4 SPONGES. 1) RFID ON 4X4 SPONGE WAS NOT DETECTED WHEN WANDED; 2) RFID HAD CHIP WITH A LOW READ RANGE; 3) RFID NOT DETECTED WHEN WANDED; 4) RFID NOT SEWN INTO TOWEL; 5) RFID HAD LOW READ RANGE; 6) RFID NOT DETECTED WHEN WANDED; 7) SPONGES FRAYING AND LEAVING PARTICULATE IN PATIENT; 8) INCORRECT # OF SPONGES IN PACK; 9) SPONGES FRAYING; 10) SPONGES FRAYING WITH PARTICULATE IN PATIENT; 11) RFID POUCHES FELL OUT OF 2 SPONGES BUT RECOVERED, APPEAR TO HAVE SEWN LINES BUT NO THREAD. NO PATIENTS WERE HARMED.WE HAVE MADE THE MANUFACTURER AWARE OF THE MULTIPLE DOCUMENTED ISSUES. THESE ISSUES HAVE OCCURRED OVER APPROXIMATELY 10 MONTHS. WE HAVE BEEN ADVISED BY THE MANUFACTURER WE ARE THE ONLY CUSTOMER EXPERIENCING THESE PROBLEMS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?1) DENTAL PROCEDURE; 2) DENTAL PROCEDURE; 3) DENTAL PROCEDURE; 4) ARTHROSCOPY PROCEDURE; 5) SPINE PROCEDUURE; 6) DENTAL PROCEDURE; 7) UROLOGY PROCEDURE; 8) ORTHO PROCEDURE; 9) UROLOGY PROCEDURE; 10) UROLOGY PROCEDURE; 11) ORTHO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109905 CLEARCOUNT COUNTER, SPONGE, SURGICAL GDY CLEARCOUNT MEDICAL SOLUTIONS, INC. * *
    109906 CLEARCOUNT COUNTER, SPONGE, SURGICAL TOWEL GDY CLEARCOUNT MEDICAL SOLUTIONS, INC. * *
    109907 CLEARCOUNT COUNTER, SPONGE, SURGICAL GDY CLEARCOUNT MEDICAL SOLUTIONS, INC. * *
    109908 CLEARCOUNT COUNTER, SPONGE, SURGICAL GDY CLEARCOUNT MEDICAL SOLUTIONS, INC. * *
    109909 CLEARCOUNT COUNTER, SPONGE, SURGICAL GDY CLEARCOUNT MEDICAL SOLUTIONS, INC. * *
    109910 CLEARCOUNT COUNTER, SPONGE, SURGICAL GDY CLEARCOUNT MEDICAL SOLUTIONS, INC. * *
    109911 CLEARCOUNT COUNTER, SPONGE, SURGICAL GDY CLEARCOUNT MEDICAL SOLUTIONS, INC. * *
    109912 CLEARCOUNT COUNTER, SPONGE, SURGICAL GDY CLEARCOUNT MEDICAL SOLUTIONS, INC. * *
    109913 CLEARCOUNT COUNTER, SPONGE, SURGICAL GDY CLEARCOUNT MEDICAL SOLUTIONS, INC. * *
    109914 CLEARCOUNT COUNTER, SPONGE, SURGICAL GDY CLEARCOUNT MEDICAL SOLUTIONS, INC. * *
    110124 CLEARCOUNT COUNTER, SPONGE, SURGICAL GDY CLEARCOUNT MEDICAL SOLUTIONS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES