BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRONIC SAFETY-SPONGE SYSTEM

    MDR report key: 877037 · Received June 4, 2007

    Report

    Report Number
    877037
    Event Type
    Malfunction
    Date Received
    June 4, 2007
    Date of Event
    June 1, 2007
    Report Date
    June 4, 2007
    Manufacturer
    SURGICOUNT MEDICAL
    Product Code
    LWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WE HAVE HAD NUMEROUS PROBLEMS WITH THE SURGICOUNT SPONGE COUNTERS. IN THIS PARTICULAR INCIDENT, STAFF REPORTED THAT THE SCREEN "FROZE AND BECAME SCRAMBLED". UPON RE-BOOTING THE DEVICE, THE COUNT AND REPORT FOR THIS CASE WERE LOST. STAFF WAS ABLE TO CONTINUE THE CASE USING A MANUAL COUNT. THE MOST COMMON PROBLEM WITH THIS DEVICE HAS BEEN THE DISPLAY FREEZING AND BECOMING UNRESPONSIVE TO ALL CONTROLS. IN MOST CASES, THE DEVICE CAN BE RE-BOOTED TO SOLVE THE PROBLEM. IN SOME CASES, STAFF MEMBERS REPORTED THE COUNT IN THE DEVICE INDICATED AN INACCURATE SPONGE COUNT WHICH SUGGESTED THAT SPONGES WERE NEVER USED DURING THE CASE. THOUGH A MANUAL COUNT IS ALWAYS MAINTAINED AS A BACKUP REGARDLESS IF A SPONGE COUNTER IS USED, DUE TO THE UNRELIABILITY OF THESE DEVICES, THE DISCREPANCIES OFTEN TIMES RESULT IN MORE WORK FOR STAFF MEMBERS. WE HAVE HAD AT LEAST 21 SEPARATE CASES OF THESE DEVICES MALFUNCTIONING, WHICH HAVE RANGED FROM FREEZING DURING USE, NOT SCANNING APPROPRIATELY, SCREENS BECOMING UNREADABLE OR SCRAMBLED, AND FIELDS OVERLAPPING. THESE PROBLEMS HAVE RESULTED IN DELAYS DURING SURGERY AND QUESTIONABLE/INACCURATE SPONGE COUNTS. THE MANUFACTURER STATED THEY WERE WORKING ON NEW SOFTWARE FOR THIS DEVICE, AND THE NEW VERSION IS SCHEDULED TO BE RELEASED SOMETIME LATER THIS MONTH. SOME DEVICES HAVE BEEN SENT BACK TO THE MANUFACTURER, BUT MOSTLY FOR REPAIR OF MECHANICAL DAMAGE. THE SOFTWARE GLITCHES SEEM TO BE TRANSIENT AND CAN USUALLY BE RESOLVED BY RE-BOOTING THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRONIC SAFETY-SPONGE SYSTEM SPONGE COUNTER LWH SURGICOUNT MEDICAL N10410 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES