BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1962004 · Received January 17, 2011

    Report

    Report Number
    3005075853-2011-00196
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. OUR INSTRUCTIONS FOR USE, UNDER "WARNINGS" STATES: "AVOID CONTACT WITH ANY AND ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS WHEN THE INSTRUMENT IS ACTIVATED. CONTACT WITH STAPLES, CLIPS OR OTHER INSTRUMENTS WHILE THE INSTRUMENT IS ACTIVATED MAY RESULT IN CRACKED OR BROKEN BLADES WHICH MAY BE IDENTIFIED BY GENERATOR SOLID TONE OR INSTRUMENT ERROR." TROUBLESHOOTING STEPS: REGARDING THE BLADE CRACKING OR BREAKING, THIS IS THE RESULT OF THE BLADE BEING DAMAGED DURING THE COURSE OF THE SURGICAL PROCEDURE DUE TO CONTACT WITH OTHER METAL INSTRUMENTS. WHEN THIS OCCURS, THE SYSTEM GIVES AN ERROR CODE OR SOLID TONE, ADVISING OF A POSSIBLE INSTRUMENT PROBLEM, AND THAT TROUBLESHOOTING STEPS MUST BE FOLLOWED. THESE STEPS ARE: TIGHTEN INSTRUMENT USING BLADE WRENCH; CLEAN DISTAL END OF THE INSTRUMENT SHEATH. DEPRESS STANDBY TO CLEAR ERROR CODE AND RETURN TO READY MODE. ACTIVATE SYSTEM IF ERROR STILL OCCURS: CONFIRM GENERATOR IS IN STANDBY MODE. INSTALL TEST TIP TO ISOLATE PROBLEM. PRESS TEST BUTTON. IF SYSTEMS FUNCTIONS WITH TEST TIP, REPLACE INSTRUMENT. IF SYSTEM FAULTS WITH TEST TIP, REPLACE HANDPIECE. WHEN THESE STEPS ARE NOT FOLLOWED, AND THE SURGEON CONTINUES TO USE THE BLADE, (WHICH MAY BE CRACKED DUE TO DAMAGE), THE CRACK CAN PROPAGATE AND RESULT IN A BROKEN BLADE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS SCRATCHED. THE DEVICE WAS ACTIVATED WITH THE GENERATOR AND AN ERROR CODE 5 WAS DISPLAYED. PROBABLE CAUSES OF BLADE DAMAGE, INCLUDING BREAKAGE, ARE EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE, BLADE CONTACT WITH OTHER DEVICES, STAPLES OR CLIPS DURING THE PROCEDURE OR USING ANY MEANS OTHER THAN THE BLADE WRENCH TO ATTACH OR DETACH THE BLADE. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE DAMAGE SEVERITY AND RESULT IN AN ERROR CODE 5 OR BLADE "LOCKOUT" LATER IN THE PROCEDURE, AND CONTINUED USAGE CAN RESULT IN A BROKEN BLADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE SURGEON WAS USING THE DEVICE TO DISSECT TISSUE AND THE INSTRUMENT AND OR GENERATOR STARTED MAKING A SOLID, DRONING NOISE. THIS CONTINUED INTERMITTENTLY, AFTER A WHILE, THE SURGEON DECIDED TO STOP USING THE INSTRUMENT AND UPON REMOVING THE INSTRUMENT FROM THE PATIENT, THE BLADE COMPONENT CAME OFF. THE SURGEON REPLACED IT WITH ANOTHER DEVICE WHICH WORKED PERFECTLY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM W ERG HANDLE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE