BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3910819 · Received July 2, 2014

    Report

    Report Number
    3005075853-2014-04620
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 2014
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED WITH THE BLADE TIP BROKE OFF AND NOT RETURNED. DURING FUNCTIONAL TESTING ON A GENERATOR THE DEVICE GAVE AN ERROR CODE 5. THE DEVICE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE OR DISPLAY AN ERROR CODE 5 ON THE GENERATOR DISPLAY WHEN THE BLADE BECOMES DAMAGED. 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 AN ERROR CODE. 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. WHEN THE BLADE IS DAMAGED AND PRIOR TO ITS BREAKING, IT IS POSSIBLE TO FAIL PRE-RUN TEST, RESULTING IN AN ERROR CODE. THIS WAS SEEN DURING OUR TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A SOLID TONE WAS HEARD AND ERROR CODE ¿5¿WAS DISPLAYED. REINSTALLED THE TITANIUM TIP BROKEN DURING THE PRE-RUN TEST. THE BROKEN PIECE DID NOT FALL INTO THE PATIENT¿S BODY. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386360 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE