BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS* CURVED SHEARS

    MDR report key: 1881639 · Received October 25, 2010

    Report

    Report Number
    3005075853-2010-06053
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 30, 2010
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): ADDED ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED IN GOOD CONDITION. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL. THE CUTTING OF THE TEST MEDIA PERFORMED AS EXPECTED. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROID PROCEDURE, THE DEVICE WAS NOT SEALING AND IT WAS TAKING MUCH LONGER THAN IT NORMALLY DOES TO SEAL TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC FOCUS* CURVED SHEARS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK G4TH9K

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE