BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 3841340 · Received May 30, 2014

    Report

    Report Number
    3005075853-2014-03680
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 20, 2014
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    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. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT PRIOR TO AN UNKNOWN PROCEDURE, THE HOSPITAL STAFF REPORTED THAT THEY OPENED THE DEVICES AND THAT ON ALL OF THEM THE INNER PACKAGING WAS OPEN ALREADY. PRODUCT COMES IN AN OUTER CARDBOARD BOX AND WITH AN INNER PLASTIC CONTAINER. IT IS BELIEVED THAT THE OUTER CARDBOARD BOX HAD NOT BEEN OPENED. ISSUE WAS NOTED BEFORE DEVICES HAD COME INTO CONTACT WITH STERILE FIELD. STOCK WAS ORDERED IN THE LAST WEEK OR TWO. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319429 HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. K4D34L

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE