BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHT HANDLE ASSEMBLY

    MDR report key: 1851913 · Received September 21, 2010

    Report

    Report Number
    2031963-2010-00121
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. THE SERIAL NUMBER WAS NOT AVAILABLE AT THE TIME OF REPORT. ATTEMPTS WILL BE MADE TO OBTAIN THIS INFO. ACTUAL DEVICE WAS EVALUATED IN THE FIELD. THE DEVICE MANUFACTURE DATE WAS NOT AVAILABLE AT THE TIME OF THE REPORT. ATTEMPTS WILL BE MADE TO OBTAIN THIS INFO. EVALUATION SUMMARY: AFTER EVALUATION BY THE FIELD SERVICE TECH, IT WAS FOUND THAT THE MALFUNCTION WAS ASSOCIATED WITH THE FLAT PANEL YOKE HANDLE DUE TO SUSTAINED DAMAGE. THE DAMAGE TO THE INTERNAL COMPONENTS OF THE HANDLE ASSEMBLY IS LIKELY FROM COVERS BEING FORCEFULLY INSTALLED OVER TIME. WITH THIS MALFUNCTION, THERE IS A POTENTIAL FOR THE STERILIZABLE COVER TO FALL OFF DURING A PROCEDURE AND INTO THE STERILE FIELD. HOWEVER, THIS SPECIFIC MALFUNCTION WAS IDENTIFIED PRIOR TO A PROCEDURE AND THERE WERE NO PTS INVOLVED AND NO EVENT OCCURRED. IN THIS CASE, THE FLAT PANEL YOKE HANDLE ASSEMBLY WAS REPLACED BY THE FIELD SERVICE TECH. THESE TYPES OF NON-CONFORMANCES ARE PART OF AN ONGOING INVESTIGATION, AND WILL CONTINUE TO BE MONITORED AND ANALYZED. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT THE STERILIZABLE COVER IN OPERATING ROOM 1 MONITOR 2 AT KETTERING MEDICAL CENTER IS NOT ABLE TO FIT CORRECTLY ON THE FLAT PANEL HANDLE. THERE WAS NO REPORTED PT INVOLVEMENT, AND NO REPORTED ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHT HANDLE ASSEMBLY BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA