BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 1190818 · Received October 7, 2008

    Report

    Report Number
    3005075853-2008-02175
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 17, 2008
    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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MASTECTOMY PROCEDURE, THE TIP OF THE ACTIVE BLADE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST LFL ETHICON ENDO-SURGERY, LLC. NA E4L46T

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR