BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINOR PACK - LF

    MDR report key: 1994418 · Received February 8, 2011

    Report

    Report Number
    1417592-2011-00006
    Event Type
    Other
    Date Received
    February 8, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 4, 2011
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS UNDERGOING A MAMOPLASTY. DURING THE PROCEDURE AN ARCH OCCURRED FROM THE TIP WHERE IT INSERTED INTO THE PENCIL. THIS RESULTED IN A BURN TO THE PATIENT. THE AREA WAS EXCISED. THE PATIENT WAS REPORTED TO BE DOING WELL. THE TIP AND PENCIL WAS RETURNED AND EVALUATED. THERE WERE CHAR MARKS ON THE CAUTERY TIP AND THE INSULATION OF THE CAUTERY TIP (INCLUDING ON THE INSULATION THAT WOULD NORMALLY BE INSIDE THE CAUTERY PENCIL WHEN THE TIP IS SEATED FULLY INTO THE PENCIL). NO CHAR MARK WAS FOUND ON THE CAUTERY PENCIL OR INSIDE THE CAUTERY PENCIL. IT APPEARS THAT THE TIP WAS NOT SEATED INTO THE PENCIL CORRECTLY AT THE TIME OF USE. THE ROOT CAUSE OF THIS INCIDENT APPEARS TO BE THE RESULT OF USER ERROR. DUE TO THE REPORTED BURN TO THE PATIENT, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    DURING A MAMMOPLASTY, THE PATIENT SUFFERED A BURN FROM THE CAUTERY PENCIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINOR PACK - LF CAUTERY TIP AND PENCIL WITHIN GEI DYNJS0104 10DZ0056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other