BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 2943216 · Received February 5, 2013

    Report

    Report Number
    3005075853-2013-00464
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K063192
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ADDED ADDITIONAL INFORMATION THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE TISSUE PAD WAS FOUND PROPERLY ATTACHED TO THE DEVICE AND IT GOOD VISUAL CONDITION. THE DEVICE WAS TESTED ON GENERATOR AND WAS FUNCTIONAL. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE INCIDENT REPORTED. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DOES NOT WORK. ANOTHER DEVICE LIKE DEVICE WAS USED TO COMPLETE THE CASE, AND LOOSED THE TISSUE PAD, IT DIDN'T FALL INTO THE PATIENT. ANOTHER DEVICE LIKE DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47614 HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J4C8JF

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE