BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2971265 · Received February 21, 2013

    Report

    Report Number
    3005075853-2013-00766
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    November 29, 2012
    Report Date
    February 4, 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 BLADE SCRATCHED AND CRACKED, BUT NOT BROKEN AS REPORTED BY THE CUSTOMER THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON GEN04 AN ERROR CODE 5 WAS DISPLAYED. A PROBABLE CAUSE OF AN ERROR CODE 5 IS BLADE DAMAGE. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE. IF THE HARMONIC SYSTEM SENSES AN INSTRUMENT FAULT DURING USE, AN AUDIBLE ALARM (TONE WITH LONG PULSES) WILL SOUND AND A VISUAL ALARM INDICATOR 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. BECAUSE THE BLADE WAS NOT BROKEN AS REPORTED, IT IS POSSIBLE THAT THE DEVICE RETURNED MAY HAVE BEEN USED TO COMPLETE THE PROCEDURE AND IS NOT THE DEVICE COMPLAINED ABOUT.

    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). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TITANIUM TIP BROKE. THE BROKEN PIECE DIDN'T FALL INTO THE PATIENT'S BODY. CHANGED TO ANOTHER ONE TO COMPETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77215 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE