BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCON

    MDR report key: 83000 · Received April 14, 1997

    Report

    Report Number
    83000
    Event Type
    Malfunction
    Date Received
    April 14, 1997
    Date of Event
    March 4, 1997
    Report Date
    March 14, 1997
    Manufacturer
    CIRCON
    Product Code
    EQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE LIGHT CORD CONNECTOR BECAME VERY HOT AND WHEN PLACED ON A FOLDED BLUE TOWEL SMOKE WAS NOTED AND A BURN THE SIZE OF A PEA WAS NOTED ON THE TOWEL. IMMEDIATE ACTION TO REMOVE THE CORD AND NO FURTHER DAMAGE OR INJURY TO PT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCON LAPAROSCOPE TELESCOPE AND CORD EQH CIRCON LAP-10-ON LAPAROSCOPE *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other