BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMALIX

    MDR report key: 3480669 · Received November 8, 2013

    Report

    Report Number
    9710055-2013-00049
    Event Type
    Injury
    Date Received
    November 8, 2013
    Date of Event
    October 8, 2013
    Report Date
    October 10, 2013
    Manufacturer
    MAQUET S.A.S.
    Product Code
    FSY
    PMA / PMN Number
    K982063
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL BIOMEDICAL ENGINEER INFORMED A FIELD SERVICE TECHNICIAN (FST) THAT FOUR CUPOLAS WERE USED SIMULTANEOUSLY TO ILLUMINATE THE PT FOR A DURATION OF FOUR HOURS; THEN TWO CUPOLAS WERE USED TO LIGHT THE SURGICAL PLAIN FOR AN ADD'L TWO HOURS. THE FST HAS BEEN ABLE TO VERIFY THAT EACH OF THE CUPOLAS USED OPERATED TO SPECIFICATION IN TERMS OF LIGHT ILLUMINATION. HOWEVER, WHEN ALL FOUR LIGHTS ARE SET TO MAXIMUM ILLUMINATION; THE FOUR CUPOLAS ARE ABLE TO DELIVER UP TO 430.000LUX TO THE SURGICAL PLAIN AND TWO CUPOLAS CAN DELIVER UP TO 230.000LUX. MAQUET BELIEVES THE ILLUMINATION SETTING OF THE LIGHTS WAS INCORRECTLY SET FOR THE PROCEDURE, INCREASING THE TEMPERATURE OF THE SURGICAL FIELD, RESULTING IN THE DRIED OUT TISSUES REPORTED. THE PRISMALIX SERIES OPERATING MANUAL INCLUDES FOLLOWING WARNING: "LIGHT IS AN ENERGY WHICH CAN POTENTIALLY DRY TISSUE. THE USER MUST ADAPT THE LIGHTING LEVEL TO THE NEEDS OF THE OPERATION TO BE PERFORMED, IN PARTICULAR WHEN SEVERAL PROJECTORS ARE USED IN COMBINATION." THE FST RETRAINED THE CUSTOMER WHO UNDERSTOOD THAT TWO CUPOLAS MAXIMUM SHOULD BE USED SIMULTANEOUSLY, WITH PROPER A LIGHT LEVEL. MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET SAS PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THE LOCAL MAQUET DISTRIBUTOR THAT THE PT'S LEG BECAME RED AND INFLAMED AFTER A 6-HOUR OPERATION. THE INFLAMED AREA WAS APPROX 3.5 INCHES LONG AND 2.5 INCHES LARGE AND LOCATED AROUND THE PT'S LEFT TIBIA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578411 PRISMALIX FSY MAQUET S.A.S. PRX8411+PRX6431 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other