BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 3792354 · Received September 10, 2010

    Report

    Report Number
    3792354
    Date Received
    September 10, 2010
    Date of Event
    March 26, 2010
    Report Date
    May 17, 2010
    Manufacturer
    *
    Product Code
    FCW
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    AT THE END OF A LAPAROSCOPIC PROCEDURE, OBT OBSTETRICS TECHNICIAN DISCONNECTED THE LENS FROM THE LIGHT CORD AND LAID ON THE DRAPE WHILE STILL CONNECTED TO THE LIGHT SOURCE. DR NOTICED IMMEDIATELY AND PICKED UP. SMALL BURN WAS ON THE DRAPE, BUT NOT ON THE TOWEL UNDERNEATH. NO INJURY TO PATIENT, BUT FIRE SAFETY RULES WERE REVIEWED WITH STAFF.======================HEALTH PROFESSIONAL'S IMPRESSION.======================STAFF SHOULD NOT ATTEMPT TO LAY DOWN LIGHT CORD WHILE STILL ATTACHED TO POWER SOURCE. STAFF REVIEWED PROPER FIRE SAFETY PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LAPROSCOPIC LIGHT FCW * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *