BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3961945 · Received July 28, 2014

    Report

    Report Number
    3005075853-2014-05277
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 24, 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). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. DURING FUNCTIONAL TESTING ON A GENERATOR THE DEVICE GAVE AN ERROR CODE 5. THE DEVICE WILL STOP ACTIVATING, AND EITHER EMITS A SOLID TONE OR DISPLAY AN ERROR CODE 5 ON THE GENERATOR DISPLAY WHEN THE BLADE BECOMES DAMAGED. THE DEVICE WAS DISASSEMBLED AND A CRACK 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 CRACKED DUE TO CONTACT WITH CLAMP ARM PIN. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE BLADE TO MAKE CONTACT WITH THE CLAMP ARM PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE SHOWED 'ERROR 5'. REINSTALLED AND STILL HAD THE SAME PROBLEM. CHANGED TO THE SECOND ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438156 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE