BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOLAP

    MDR report key: 280907 · Received June 8, 2000

    Report

    Report Number
    MW1019080
    Event Type
    Malfunction
    Date Received
    June 8, 2000
    Date of Event
    June 8, 2000
    Report Date
    June 8, 2000
    Manufacturer
    ENDOLAP, INC
    Product Code
    EQH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DELIVERY END OF THE CORD IS A LIGHT CARRIER AND IT STICKS OUT OVER THE COUPLER END BY ABOUT 3-4MM. THE LIGHT CORD WAS LAID ON A TOWEL IN A STERILE FIELD AND WHEN IT WAS TURNED ON, WITHIN SECONDS, THE TOWEL CAUGHT FIRE. RPTR STATES THAT A COMPETITOR MAKES THE SAME TYPE OF CORD WHICH HAS A COVER GUARD FOR THE END. RPTR BELIEVES THAT IF DEVICE HAD THIS GUARD THE FIRE WOULD NOT HAVE STARTED. MFR WAS NOTIFIED ABOUT EVENT AND IS INVESTIGATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOLAP FIBEROPTIC LIGHT CORD 0.4MM X 10FT EQH ENDOLAP, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA