BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS FOCUS 17 CM CURVED SHEAR

    MDR report key: 2190141 · Received August 4, 2011

    Report

    Report Number
    3005075853-2011-03182
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K063192
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT ONLY YEAR KNOWN, ASSUMED (B)(6) OF MONTH ((B)(6)) THAT COMPLAINT WAS REPORTED ADDITIONAL INFORMATION: THE SALES REP WAS PRESENT DURING THE ORIGINAL PROCEDURE AND BELIEVES SURGEON TECHNIQUE COULD HAVE CONTRIBUTED TO ISSUE. THE SURGEON USED ONLY THE TIP OF THE DEVICE TO SEAL CERTAIN AREAS INSTEAD OF THE CENTER OF JAW. THE SURGEON WAS INSTRUCTED THE CORRECT TISSUE PLACEMENT TO SEAL TISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL WEEKS POST-OP FROM A MASTECTOMY PROCEDURE, EXCESSIVE DRAINAGE OF LYMPHATIC FLUID WAS NOTICED. THE PATIENT HAD TO HAVE FLUID REMOVED USING A NEEDLE ONCE A WEEK FOR (B)(6) FOLLOWING THE SURGERY. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS FOCUS 17 CM CURVED SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR AND HANDPIECE