BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 4780795 · Received May 19, 2015

    Report

    Report Number
    3005075853-2015-03141
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    May 8, 2015
    Report Date
    May 12, 2015
    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). NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION RECEIVED: THE PROCEDURE WAS OPEN COLECTOMY. THE BLADE WAS BROKEN INTO THE PATIENT AND THE BROKEN BLADE WAS RETRIEVED FROM THE PATIENT WITH A PAIR OF TWEEZERS. NO PIECES WAS LEFT INSIDE. THE BROKEN BLADE TIP WON¿T RETURNED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BLADE WAS BROKEN OFF DURING USE. NO PIECES WERE LEFT INSIDE THE PATIENT.. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325532 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA M9026E

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE