BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL

    MDR report key: 2243944 · Received September 2, 2011

    Report

    Report Number
    2243944
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 24, 2011
    Report Date
    September 2, 2011
    Manufacturer
    ETHICON ENDO - SURGERY INC
    Product Code
    NLQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF HARMONIC SCALPEL DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE TEFLON INLAY ON THE "JAW" FELL OFF OF THE DEVICE (BROKE AWAY) FALLING INTO THE ABDOMEN, AND THE INSTRUMENT BECAME ADHERED TO TISSUE. THE SURGEON RETRIEVED THE BROKEN OFF TEFLON PIECE FROM THE ABDOMEN. AFTER SEVERAL MINUTES, THE SURGEON WAS ABLE TO FREE THE SCALPEL FROM THE TISSUE IT WAS ADHERED TO. ALL PIECES WERE REMOVED FROM THE FIELD & SEQUESTERED. A NEW HARMONIC SCALPEL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL SURGICAL - ULTRASONIC CURVED SHEARS NLQ ETHICON ENDO - SURGERY INC ACE36E

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention