BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUM LED II SURGICAL LIGHT

    MDR report key: 2440616 · Received January 20, 2012

    Report

    Report Number
    2031963-2012-00009
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    December 27, 2011
    Report Date
    December 27, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT INVOLVEMENT, THEREFORE, NO PT DATA EXISTS. PHOTOGRAPHIC IMAGES WERE TAKEN OF THE SUSPENSION WITH THE ALLEGED FLAKING PAINT AND THE ACTUAL DEVICE WAS EVALUATED IN THE FIELD AND REPLACED ON (B)(4) 2012. THE AFFECTED SUSPENSION IS BEING RETURNED TO THE OEM FOR FURTHER EVAL. EVAL SUMMARY: THE AFFECTED COMPONENTS HAVE NOT YET BEEN RETURNED TO THE OEM MFR FOR FURTHER EVAL, HOWEVER, PHOTOGRAPHIC IMAGES HAVE BEEN PROVIDED. FROM AN EVAL OF THE PHOTOGRAPHS, IT WOULD APPEAR THAT THE TRIGGERING EVENT IS CORROSION FORMING UNDER THE PAINT LAYER. IN THIS INSTANCE THERE WAS NO REPORTED PT 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

    (B)(4). IT WAS REPORTED THAT PAINT WAS ALLEGEDLY FLAKING OFF OF THE LED SURGICAL LIGHT SUSPENSION. THERE WAS NO REPORTED PT 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

    Patients

    Seq Age Sex Outcome Treatment
    1