BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUM LED II SURGICAL LIGHT

    MDR report key: 2479567 · Received February 23, 2012

    Report

    Report Number
    2031963-2012-00028
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    January 30, 2012
    Report Date
    January 30, 2012
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE, NO PATIENT DATA EXISTS. THE CAMERA COVERS INVOLVED IN THIS REPORT WERE RETURNED FOR EVALUATION ON (B)(4) 2012. 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 COVERS WAS REPORTED TO HAVE FALLEN OUT OF THE COVER. THE CAMERA COVERS HAVE BEEN RETURNED TO THE MANUFACTURER AND VISUALLY EVALUATED. 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. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4): IT WAS REPORTED THAT FOLLOWING A SINGLE WASH-CYCLE, THE LENS OF THE INLIGHT CAMERA COVER WAS ALLEGEDLY CRACKED. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO ADVERSE CONSEQUENCE REPORTED.

    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