BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3190318 · Received June 26, 2013

    Report

    Report Number
    3005075853-2013-03290
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPG, THE BLADE WAS BROKEN OFF OUTSIDE THE PATIENT IN THE MIDDLE OF THE OPERATION. NO BROKEN PIECES FELL INTO THE PATIENT. THE DEVICE WAS USED IN THE STOMACH. GEN04 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290768 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK K90G6V

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE