BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3170213 · Received June 14, 2013

    Report

    Report Number
    3005075853-2013-03013
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS SHOULD THE DEVICE BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE SENT

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2013. INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. 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). 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 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE A GASTRECTOMY, AN ERROR 5 WAS DISPLAYED AT THE SYSTEM CHECK. THEN THE BLADE WAS BROKEN OFF DURING THE PRE-RUN TEST. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271439 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE