BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    .

    MDR report key: 4953830 · Received July 30, 2015

    Report

    Report Number
    3005075853-2015-04800
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    June 22, 2015
    Report Date
    July 15, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K132612
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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. BATCH #UNK.

    Description of Event or Problem · 1

    PER USER FACILITY MEDWATCH REPORT FORM (B)(4) ADVISED THAT DURING A RESECTION OF FEMORAL ARTERY ANEURYSM PROCEDURE; THE TIP OF THE DEVICE BROKE OFF. THE TIP WAS FOUND. THE PROCEDURE WAS COMPLETED USING ANOTHER INSTRUMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496352 . INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA M4HE34

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR GENERATOR AND HANDPIECE