BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ATT

    MDR report key: 3773927 · Received April 25, 2014

    Report

    Report Number
    3005075853-2014-02845
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 22, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE BLADE TIP BROKE OFF RETURNED. DURING FUNCTIONAL TESTING ON A GENERATOR THE DEVICE GAVE AN ALERT SCREEN. THE DEVICE WILL STOP ACTIVATING, AND DISPLAY AN ALERT SCREEN ON THE GENERATOR WHEN THE BLADE BECOMES DAMAGED. THE DEVICE WAS DISASSEMBLED AND THE BREAK WAS LOCATED INSIDE THE TUBE PROXIMAL TO THE TISSUE PAD. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE DAMAGE SEVERITY AND RESULT IN ALERT SCREENS, SUCH AS ¿TIGHTEN ASSEMBLY¿ OR ¿BLADE ERROR DETECTED¿ "RELAXED PRESSURE IN BLADE" FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE. THE ANALYSIS CONCLUDED THAT THE BLADE BROKE OFF DUE TO CONTACT WITH THE CLAMP ARM PIN. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE BLADE TO MAKE CONTACT WITH THE CLAMP ARM PIN. IT IS POSSIBLE THAT THE UNEXPECTED NOISE HEARD COULD BE EITHER: (1) THE BLADE MAKING CONTACT WITH METAL OR PLASTIC WHILE ACTIVATED AS STATED FROM THE COMPLAINT; (2) THE BLADE NOT PROPERLY ATTACHED TO THE HANDPIECE; OR (3) THE SOLID TONE EMITTED WHEN THE BLADE BECOMES DAMAGED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING A LAPAROSCOPIC HYSTERECTOMY ENDOMETRIOSIS PROCEDURE, WHICH WAS VERY FIBROTIC DUE TO ENDOMETRIOSIS. THE TIP FELL OFF AFTER TWO AND ONE HALF HOURS OF OPERATING. THE TIP SHEARED OFF NEAR THE VERY PROXIMAL PART OF THE JAWS. THE SURGEON ASSISTING THE MAIN SURGEON CALLED AND NOTICED IT FIRST. I HAD HEARD A FEW "SCRATCH" SOUNDS DURING THE CASE WHEN THE UNINTENTIONALLY CAME IN TO CONTACT WITH THEIR OTHER INSTRUMENTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. SURGERY WAS PROLONGED FIVE MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED. AFFILIATE REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252674 HARMONIC ACE ATT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE