BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1953913 · Received January 10, 2011

    Report

    Report Number
    3005075853-2011-00084
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 6, 2011
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. EES REFURBISHING LETTER ATTACHED OUR INSTRUCTIONS FOR USE WARN: "AUDIBLE HIGH-PITCHED TONES, RESONATING FROM THE BLADE OR HAND PIECE, ARE AN ABNORMAL CONDITION AND AN INDICATOR THAT THE BLADE OR HAND PIECE IS NOT OPERATING PROPERLY. THE TONES MAY BE AN INDICATOR THAT THE HAND PIECE IS BEYOND ITS USEFUL LIFE OR THAT THE BLADE HAS NOT BEEN ATTACHED PROPERLY, WHICH MAY RESULT IN ABNORMALLY HIGH SHAFT TEMPERATURES AND USER OR PATIENT INJURY." "BLOOD AND TISSUE BUILDUP BETWEEN THE BLADE AND SHAFT MAY RESULT IN ABNORMALLY HIGH TEMPERATURES AT THE DISTAL END OF THE SHAFT. TO PREVENT BURN INJURY, REMOVE ANY VISIBLE TISSUE BUILDUP AT THE DISTAL END OF THE SHAFT." "TO AVOID USER OR PATIENT INJURY IN THE EVENT THAT ACCIDENTAL ACTIVATION OCCURS, THE INSTRUMENT BLADE, CLAMP ARM, AND DISTAL END OF THE SHAFT SHOULD NOT BE IN CONTACT WITH THE PATIENT, DRAPES, OR FLAMMABLE MATERIALS WHILE NOT IN USE." "DURING AND FOLLOWING ACTIVATION IN TISSUE, THE INSTRUMENT BLADE, CLAMP ARM, AND DISTAL 7 CM OF THE SHAFT MAY BE HOT. AVOID UNINTENDED CONTACT WITH TISSUE, DRAPES, SURGICAL GOWNS, AT ALL TIMES." "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." "CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. CLAMPING THE TISSUE PAD AGAINST THE ACTIVE BLADE WITHOUT TISSUE ON THE FULL LENGTH OF THE BLADE WILL RESULT IN HIGHER BLADE, CLAMP ARM AND DISTAL SHAFT TEMPERATURES AND CAN RESULT IN POSSIBLE DAMAGE TO THE INSTRUMENT. IF THIS HAPPENS, THERE MAY BE A SYSTEM FAILURE SIGNALED BY A CONTINUOUS TONE OR ERROR CODE WHEN EITHER OF THE FOOT PEDALS OR HAND CONTROL BUTTON IS DEPRESSED." "KEEP THE CLAMP ARM OPEN WHEN BACKCUTTING OR WHILE THE BLADE IS ACTIVE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD AND INCREASED BLADE, CLAMP ARM AND DISTAL SHAFT TEMPERATURES." "THE ENTIRE EXPOSED BLADE TIP AND ANY EXPOSED BLADE SHAFT IS ACTIVE AND WILL CUT/COAGULATE TISSUE WHEN THE INSTRUMENT BLADE IS ACTIVATED. BE CAREFUL TO AVOID INADVERTENT CONTACT BETWEEN ALL EXPOSED BLADE SURFACES AND SURROUNDING TISSUE WHEN USING THE CURVED SHEARS." "INCIDENTAL AND PROLONGED ACTIVATION AGAINST SOLID SURFACES, SUCH AS BONE, MAY RESULT IN BLADE HEATING AND SUBSEQUENT BLADE FAILURE, AND SHOULD BE AVOIDED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE SWITCH BUTTONS ON DEVICE WORKED INTERMITTENTLY. WHILE USING THE SAME DEVICE, THE BLADE BROKE OFF INTO THE PATIENT. THE BROKEN BLADE WAS ABLE TO BE RETRIEVED THROUGH THE TROCAR. AT THIS POINT, A BURN WAS NOTICED ON THE BOWEL NEAR THE ANASTOMOSIS WHICH WAS STATED TO BE CAUSED BY THE SHAFT OF THE DEVICE. THE SURGEON FELT THAT THE BURN WAS NOT SEVERE ENOUGH TO REQUIRE OVER-SEWING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HANDPIECE WAS GIVEN TO THE SALES REP. IN WHICH IT WAS NOTICED TO BE REFURBISHED. THE CUSTOMER WILL NOT RELEASE DEVICE.

    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 REFURBISHED HANDPIECE, EES GENERATOR