BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUM LED II SURGICAL LIGHT

    MDR report key: 2802518 · Received October 19, 2012

    Report

    Report Number
    2031963-2012-00144
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE, NO PATIENT DATA EXISTS. THE CAMERA COVER INVOLVED IN THIS REPORT HAS NOT YET BEEN RETURNED FOR EVALUATION. ADDITIONAL INVESTIGATION IS ONGOING. THE CATALOG NUMBER PROVIDED IS FOR THE IN-LIGHT CAMERA COVER, WHICH IS THE COMPONENT IDENTIFIED AS ALLEGEDLY MALFUNCTIONING. EVALUATION SUMMARY: THE GLASS OF THE STERILIZABLE IN-LIGHT CAMERA COVER WAS REPORTED TO HAVE SHOWN SIGNS OF CRACKING. SAMPLES OF THESE CRACKED CAMERA COVERS FROM PREVIOUS REPORTS HAVE BEEN RETURNED TO THE MANUFACTURER AND VISUALLY EVALUATED ALTHOUGH THE CAMERA COVERS INVOLVED IN THIS PARTICULAR EVENT HAVE NOT YET BEEN RETURNED. FURTHERMORE, A STRYKER ENGINEER VISITED A CUSTOMER ACCOUNT FOR ADDITIONAL EVALUATION REGARDING THE USE, CLEANING, AND STERILIZING OF THE CAMERA COVERS BUT NO CONCLUSION AS TO THE CAUSE OF THIS REPORTED EVENT CAN BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORT OF ANY ADVERSE CONSEQUENCES TO THE PATIENT OR CAREGIVER.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT AN IN-LIGHT CAMERA COVER HAS SHOWN SIGNS OF THE GLASS CRACKING. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO ADVERSE CONSEQUENCE REPORTED. AS THREE IN-LIGHT CAMERA COVERS WERE REPORTED TO HAVE THIS CONDITION, A SECOND MEDWATCH REPORT WILL BE FILED UNDER 2031963-2012-00145, AND A THIRD MEDWATCH REPORT WILL BE FILED UNDER 2031963-2012-00146.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISUM LED II SURGICAL LIGHT FSY STRYKER COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1