BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUM LED II SURGICAL LIGHT

    MDR report key: 2427399 · Received January 4, 2012

    Report

    Report Number
    2031963-2012-00005
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Date of Event
    December 7, 2011
    Report Date
    December 7, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE NO PATIENT DATA EXISTS. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. THE AFFECTED LIGHT HANDLE IS BEING RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. EVALUATION SUMMARY: THE AFFECTED COMPONENTS HAVE NOT YET BEEN RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION, HOWEVER PHOTOGRAPHIC IMAGES HAVE BEEN PROVIDED. FROM AN EVALUATION OF THE PHOTOGRAPHS, IT WOULD APPEAR THAT THE TRIGGERING EVENT IS CORROSION FORMING UNDER THE PAIN LAYER. THER IS A POTENTIAL RISK TO SAFETY IF PAINT WERE TO FLAKE OFF INTO THE STERILE FIELD. IN THIS INSTANCE THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO REPORT OF ANY PAINT FLAKING OFF DURING A SURGICAL PROCEDURE. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    STRYKER REFERENCE (B)(4). IT WAS REPORTED THAT THE CUSTOMER ALLEGED THAT THE PAINT WAS FLAKING OFF OF THE LED SURGICAL LIGHT HANDLE. THERE WAS NO REPORTED PATIENT INVOLVEMENT 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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA