BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUM LED WEIGHTED LIGHT HANDLE

    MDR report key: 2190949 · Received July 19, 2011

    Report

    Report Number
    2031963-2011-00070
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF SPECIFIC PT IMPACT, AND THUS NO PT INFORMATION IS AVAILABLE. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. EVALUATION SUMMARY: IT WAS REPORTED THAT THE WEIGHTED LIGHT HANDLE HAD PAINT PEELING OFF. EVEN THOUGH THE FLAKING OCCURS UNDER THE STERILIZABLE HANDLE, THE FLAKES COULD BECOME DISLODGED DURING REMOVAL OF THE HANDLE AT ANY TIME WHILE THE STERILE FIELD IS EXPOSED. THIS PARTICULAR PRODUCT BEING SHIPPED BACK TO STRYKER COMMUNICATIONS FOR FURTHER ANALYSIS. PAINT CHIPPING/FLAKING OR ADHESION ISSUES CAN LEAD TO THE PAINT FALLING INTO THE STERILE FIELD. IF THIS OCCURRED DURING A CASE AND THERE IS AN OPEN WOUND, THE PAIN COULD POTENTIALLY FALL INTO THE WOUND SITE AND POSE A SERIOUS HEALTH RISK. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES REPORTED IN THIS INSTANCE. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT A CUSTOMER CALLED STATING THE WEIGHTED LIGHT HANDLE HAD PAINT PEELING OFF, AND THAT IT WAS A POTENTIAL OH&S ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISUM LED WEIGHTED LIGHT HANDLE FSY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK