BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLSEN

    MDR report key: 138038 · Received December 9, 1997

    Report

    Report Number
    2916288-1997-00009
    Event Type
    Injury
    Date Received
    December 9, 1997
    Date of Event
    November 12, 1997
    Report Date
    December 5, 1997
    Manufacturer
    OLSEN ELECTROSURGICAL, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A TONSILECTOMY, BOTH CORNERS OF THE PT'S MOUTH WERE INADVERTENTLY BURNED. A TINY CRACK IN THE INSULATION WAS NOTED AND BELIEVED TO HAVE BEEN THE SOURCE OF THE INJURY WHEN IT CAME IN CONTACT WITH THE PT'S COMISSURE (ORAL). THE DEVICE WAS INSPECTED PRIOR TO THE EVENT AND NO CRACK WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN MONOPOLAR FORCEPS GEI OLSEN ELECTROSURGICAL, INC. 121-A 016685

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other