BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 1082933 · Received July 25, 2008

    Report

    Report Number
    3005075853-2008-00701
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 10, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT DEVICE A WAS RETURNED IN GOOD CONDITION. THE TISSUE PAD WAS IN GOOD CONDITION AND COMPLETE. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. THE ANALYSIS RESULTS FOUND THAT DEVICE B WAS RETURNED AND THE TISSUE PAD MISSING. AS THE TISSUE PAD WAS NOT RETURNED, FURTHER EVAL COULD NOT BE PERFORMED. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. THE BATCH RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS. DEVICE B ADD'L INFO: BATCH D9EF7F, EXPIRATION DATE: 02/2013, MFG DATE: 03/2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BI-LATERAL MASECTOMY PROCEDURE, THE DEVICE PAD CAME OFF IN THE PT. THE PAD WAS RETRIEVED AND THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT REPORTED.

    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 E4KV8D

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR