BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 530332 · Received May 21, 2004

    Report

    Report Number
    530332
    Event Type
    Injury
    Date Received
    May 21, 2004
    Date of Event
    May 10, 2004
    Report Date
    May 20, 2004
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WITH LEFT MAXILLARY SINUS MUCOEPIDERMOID CARCINOMA UNDERWENT A MAXILLECTOMY AND SPLIT THICKNESS GRAFT. DURING THE SURGERY THE PT SUSTAINED A FULL THICKNESS BURN TO THE LEFT UPPER LIP FROM THE BIPOLAR CAUTERY THAT WAS BEING USED. THE PT WILL REQUIRE PLASTIC SURGERY TO REPAIR THE DEFECT IN THE LIP. THE EQUIPMENT IS UNDERGOING EVAL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BIPOLAR FORCEPS GEI OLSEN MEDICAL * 113828
    2 SABRE 2400 ELECTROSURGICAL UNIT GEI CONMED ELECTROSURGERY 60-5600-002 *
    3 * DISPOSABLE BIPOLAR CORD GEI CONMED ELECTROSURGERY * 040107-1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| O| R BIPOLAR FORCEPS, CORD AND ESU.