BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY

    MDR report key: 3760786 · Received April 21, 2014

    Report

    Report Number
    3005075853-2014-02726
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 5, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND IT WAS RETURNED. THE REMAINING BLADE PORTION WAS SCRATCHED. THIS BLADE TIP PORTION MAY HAVE BROKEN OFF OF THE DEVICE DURING TRANSPORT TO OUR ANALYSIS SITE. THE REPORTED COMPLAINT WAS FOR MULTIPLE UNSPECIFIED ERROR SCREENS THAT WERE DISPLAYED DURING THE PROCEDURE. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON GEN11 AN ALERT SCREEN WAS DISPLAYED. A PROBABLE CAUSE OF AN ALERT SCREEN IS BLADE DAMAGE. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE. IF THE HARMONIC SYSTEM SENSES AN INSTRUMENT FAULT DURING USE, AN AUDIBLE ALARM (TONE WITH LONG PULSES) WILL SOUND AND A VISUAL ALARM INDICATOR WILL APPEAR ON THE CONTROL PANEL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE CAUSED MULTIPLE UNSPECIFIED ERROR SCREENS DURING AN UNKNOWN CASE. THE CASE WAS COMPLETED WITH A SECOND SAME DEVICE. NO PATIENT CONSEQUENCE. DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239431 HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE