BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL CURVED

    MDR report key: 3973341 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05406
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    April 2, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. PIN HOLE. THE DEVICE WAS RECEIVED WITH THE CLAMP ARM DETACHED FROM THE INNER TUBE BUT FIRMLY ATTACHED TO THE OUTER TUBE. AS A RESULT OF THE CLAMP ARM DETACHMENT, THE TUBE ASSEMBLY WAS DISTORTED. THE DEVICE WAS CONNECTED TO THE GENERATOR, DUE TO ITS CONDITION NOT ALL FUNCTIONAL TESTING COULD BE PERFORMED. DURING FUNCTIONAL TESTING ON GEN11 AN ALERT SCREEN WAS DISPLAYED. THE DEVICE WAS DISASSEMBLED AND IT WAS FOUND THAT THE BLADE WAS CRACKED AT THE PIN HOLE UNDER THE SHROUD OF THE DEVICE. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE DAMAGE SEVERITY AND RESULT IN ALERT SCREENS, SUCH AS ¿TIGHTEN ASSEMBLY¿, ¿BLADE ERROR DETECTED¿ OR "RELAXED PRESSURE ON BLADE" FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE. POSSIBLE CAUSES OF THE CLAMP ARM DETACHMENT ARE NOT CLOSING THE TRIGGER WHEN SLIDING THE TORQUE WRENCH ON AND OFF; NOT CLOSING THE TRIGGER WHEN INTRODUCING OR REMOVING THROUGH THE TROCAR; OR POSSIBLE ENTANGLEMENT IN FIBROUS TISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CS14C WAS BEING USED IN A MASTECTOMY, ACTIVATED FOR FIVE MINUTES, STOPPED ACTIVATING AND GAVE A TIGHTEN ASSEMBLY MESSAGE, FOLLOWED BY A REPLACE INSTRUMENT MESSAGE. A SECOND DEVICE WAS USED TO COMPLETE THE CASE WITH NO CONSEQUENCE TO THE PATIENT. ONE DEVICE WILL BE RETURNED FOR ANALYSIS BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450612 HARMONIC SCALPEL CURVED ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA L4E003

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE