BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOPOLAR FORCEPS, POTTSMITH

    MDR report key: 809561 · Received January 23, 2007

    Report

    Report Number
    1530493-2007-00005
    Event Type
    Other
    Date Received
    January 23, 2007
    Date of Event
    September 24, 2004
    Report Date
    January 22, 2007
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NOTED IN THE EVENTS SECTION, THE DOCTOR NOTED THAT A BREACH IN THE INSULATION CAUSED A BURN TO PATIENT. BASED UPON THE DOCUMENTATION SUBMITTED BY THE DOCTOR, AND THE INVESTIGATION PERFORMED BY, THIS IS PROBABLE USER ERROR. THE DOCTOR NOTED THAT WHEN THE DEVICE COMES IN CONTACT WITH ANY METAL OBJECT, THE CHANCE OCCURS FOR HEATING UP AND BREACH IN THE INSULATION. THIS NOT A FAULT OF THE DEVICE.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT THE COATING CAME OFF AND THE PATIENT GOT BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR FORCEPS, POTTSMITH MONOPOLAR FORCEPS GEI OLSEN MEDICAL E88-5240 112772

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other