BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2822883 · Received November 7, 2012

    Report

    Report Number
    3005075853-2012-05054
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 17, 2012
    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
    PA, US
    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 WITH THE BLADE SCRATCHED AND CRACKED, NOT BROKEN OFF AS REPORTED BY THE CUSTOMER. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR AND DURING FUNCTIONAL TESTING ON GEN11 INSTRUMENT ERROR SCREEN WAS RECEIVED AND WHEN TESTED WITH GEN04 AN ERROR CODE 5 WAS DISPLAYED. THE DEVICE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 WITH THE GEN04 GENERATOR; OR ON THE GEN11 GENERATOR, WILL SOUND AND A VISUAL ALARM INDICATOR (YELLOW ALERT SCREEN) WILL APPEAR IN THE LCD PANEL. THE GENERATOR SYSTEM STOP OUTPUT, SIGNAL AUDIBLY, AND PROVIDE RECOVERY INSTRUCTIONS TO THE CLINICAL STAFF THROUGH THE LCD. IT IS POSSIBLE THAT THE DEVICE RETURNED MAY HAVE BEEN USED TO COMPLETE THE PROCEDURE AND IS NOT THE DEVICE COMPLAINED ABOUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE SURGEON WENT ACROSS A STAPLE LINE DURING ACTIVATION AND THE ACTIVE BLADE BROKE OFF. IT DID NOT FALL INTO THE PATIENT, THERE WAS A GENERATOR ALERT SCREEN ERROR NOTED. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE IS RETURNING FOR ANALYSIS.

    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