BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3052312 · Received April 11, 2013

    Report

    Report Number
    3005075853-2013-01721
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 5, 2013
    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 DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND MISSING. THE REMAINING BLADE PORTION WAS SCRATCHED - EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. THIS BLADE TIP PORTION MAY HAVE BROKEN OFF OF THE DEVICE DURING TRANSPORT TO OUR ANALYSIS SITE. THE REPORTED COMPLAINT WAS FOR AN ERROR CODE 5. IF THE GEN04 SYSTEM SENSES A GENERATOR, HAND PIECE, OR INSTRUMENT FAULT DURING USE, AN AUDIBLE ALARM (TONE WITH LONG PULSES) WILL SOUND AND A VISUAL ALARM INDICATOR, SUCH AS: 'ERROR CODE 5: INSTRUMENT' WILL APPEAR ON THE CONTROL PANEL. THE GENERATOR SYSTEM WILL REVERT TO STANDBY MODE, WHEN THE AUDIBLE ALARM (SOLID TONE) AND VISUAL ALARM INDICATOR APPEAR. WHEN THIS OCCURS, THE INSTRUMENT WILL STOP ACTIVATING. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR AND AN ERROR CODE 5 (INSTRUMENT ERROR) WAS DISPLAYED. WHEN A BLADE HAS BEEN COMPROMISED SUCH AS SCRATCHED OR CRACKED, THE TITANIUM METAL IS FATIGUED WHEN CONTINUALLY ENERGIZED AND THIS RESULTS IN THE BLADE FURTHER CRACKING AND POSSIBLY BREAKING OFF. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THERE WAS A SOLID TONE WITH ERROR CODE 5. CHANGED TO ANOTHER 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
    156989 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE