BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3830273 · Received May 23, 2014

    Report

    Report Number
    3005075853-2014-03524
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 A LAP SIGMOIDECTOMY, THE BLADE WAS BROKEN OFF SOON WHEN A SCRUB NURSE CLEANED THE DEVICE. NO ERROR CODE WAS DISPLAYED. NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307434 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA L9009Z

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE