BEUDAMED
    FDA Adverse Event Other Summary report: N

    HARMONIC SCALPEL

    MDR report key: 493697 · Received November 5, 2003

    Report

    Report Number
    493697
    Event Type
    Other
    Date Received
    November 5, 2003
    Date of Event
    August 1, 2003
    Report Date
    August 1, 2003
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS UNDERGOING A LAPAROSCOPIC CHOLECYSTECTOMY, INTRAOPERATIVE CHOLANGIOGRAM, LAPAROSCOPIC REDUCTIONS, AND REPAIR OF AN INTERNAL HERNIA. A HARMONIC SCALPEL WAS TAKEN FROM AN AUTOCLAVE AND PLACED ON THE BACK TABLE IN THE OR. PRIOR TO BEGINNING WITH THE SURGERY, THE HANDLE OF THE HARMONIC SCALPEL WAS INADVERTENTLY LAID ON THE PATIENT'S UPPER ABDONMEN, CAUSING A SUPERFICIAL BURN WITH BLISTERING. THIS WAS FELT TO BE ONLY PARTIAL THICKNESS. NO OTHER INJURY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL SCALPEL LFL ETHICON ENDO-SURGERY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other