BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE + 7

    MDR report key: 5893439 · Received August 22, 2016

    Report

    Report Number
    3005075853-2016-04723
    Event Type
    Malfunction
    Date Received
    August 22, 2016
    Date of Event
    July 29, 2016
    Report Date
    August 1, 2016
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 8/22/2016. BATCH # UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MIE IVOR LEWIS ESOPHAGECTOMY PROCEDURE, THE TEFLON TISSUE PAD WAS MELTED AND FELL OFF CLAMP ARM. TISSUE PAD WAS RECOVERED COMPLETELY FROM PATIENT. CASE COMPLETED WITH LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544795 HARMONIC ACE + 7 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA M92K6EC

    Patients

    Seq Age Sex Outcome Treatment
    1