BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUM LED II SURGICAL LIGHT

    MDR report key: 2440618 · Received January 20, 2012

    Report

    Report Number
    2031963-2012-00010
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    December 28, 2011
    Report Date
    December 29, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT INVOLVEMENT, THEREFORE, NO PT DATA EXISTS. THREE CAMERA COVERS FROM AN EARLIER REPORT WITH THE CRACKED GLASS CONDITION WERE RETURNED TO THE MFR AND VISUALLY EVALUATED ON (B)(4) 2011. THE ACTUAL CAMERA COVER FROM THIS REPORT WAS NOT RETURNED AND EVALUATED, BUT REPORTEDLY EXHIBITED A SIMILAR CONDITION AS THE PREVIOUSLY EVALUATED COVERS. ADD'L EVAL IS BEING PURSUED. THE CATALOG NUMBER PROVIDED IS FOR THE IN-LIGHT CAMERA COVER WHICH IS THE COMPONENT IDENTIFIED AS ALLEGEDLY MALFUNCTIONING. EVAL SUMMARY: THE GLASS OF THE STERILIZABLE IN-LIGHT CAMERA COVERS WAS REPORTED TO HAVE SHOWN SIGNS OF CRACKING. SAMPLES OF THESE CRACKED CAMERA COVERS HAVE BEEN RETURNED TO THE MFR AND VISUALLY EVALUATED AND ARE CURRENTLY BEING SENT OUT FOR ADD'L EVAL. NO CONCLUSION WAS TO THE CAUSE OF THIS REPORTED EVENT CAN BE DETERMINED AT THIS TIME. THERE WAS NO PT INVOLVEMENT AND NO REPORT OF ANY ADVERSE CONSEQUENCES TO THE PT OR CAREGIVER. THIS IS NOT A SINGLE USE DEVICE.

    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 PT 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