BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2002740 · Received February 28, 2011

    Report

    Report Number
    3005075853-2011-00769
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE BLADE BROKEN OFF AND PRESENT. DURING FUNCTIONAL TESTING ON A GENERATOR THE DEVICE GAVE AN ERROR CODE 5. THE LOCATION OF THE BREAK IS INSIDE THE TUBE PROXIMAL TO THE TISSUE PAD. THE ANALYSIS CONCLUDED THAT THE BLADE BROKE DUE TO CONTACT WITH THE INNER TUBE. THIS DAMAGE WAS MOST LIKELY DUE TO EXCESSIVE SIDE FORCES APPLIED TO THE BLADE WHILE ACTIVATING RESULTING IN BLADE CONTACT WITH THE INNER TUBE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TITANIUM TIP OF THE SCALPEL WAS BROKEN WHEN TESTED OUTSIDE OF THE PATIENT. THE BROKEN PIECE DID NOT FALL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE