BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SYNERGY* DISSECTING HOOK WITH TORQUE WRENCH

    MDR report key: 3848371 · Received June 4, 2014

    Report

    Report Number
    3005075853-2014-03767
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K012176
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION AND RETURNED OUTSIDE ITS STERILE PACKAGE. UPON VISUAL INSPECTION IT WAS NOTED THAT THE BLADE ON THE DEVICE WAS INCORRECT. BATCH K92812 IS FOR AN SNGHK CODE AND THE INSTRUMENT HAS A SNGHK2 BLADE. THE DEVICE WAS TESTED ON THE GENERATOR AND WAS FUNCTIONAL. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. THE INCORRECT SELECTION OF THE BLADE WAS LIKELY AN ISSUE WITH OUR MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CABG, THE SHAPE OF THE BLADE WAS DIFFERENT FROM THE SHAPE OF SNGHK. . 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
    327264 HARMONIC SYNERGY* DISSECTING HOOK WITH TORQUE WRENCH INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE