BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 3.0S

    MDR report key: 6036852 · Received October 18, 2016

    Report

    Report Number
    1226420-2016-00157
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 7, 2016
    Report Date
    October 14, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): BRIEF DESCRIPTION OF COMPLAINT: THE HEAT SHRINK STARTED TO PEEL AND MOVE UP THE SHAFT TOWARDS THE BLADE. NOTHING DETACHED FROM THE DEVICE OR FELL INTO THE PATIENT. INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) LHR REVIEW COMPLAINT DEVICE DETAILS: DEVICE NAME: PLASMABLADE 3.0S, PRODUCT NUMBER: PS210-030S, LOT NUMBER: FL50908203, EXPIRATION DATE: 22-DEC-2016, QUANTITY RETURNED: 1 VISUAL INSPECTION: TESTING PERFORMED: DEVICE PACKAGING INSPECTION: ONE RETURNED PLASMABLADE 3.0S DEVICE WITH LOCKING MECHANISM WAS RECEIVED INSIDE A (B)(6) SHIPPER BOX WITHIN A BIOHAZARD BAG WITH PAPER TO FILL THE NEGATIVE SPACE. THE PLASTIC TRAY AND THE TYVEK LID WERE RETURNED; THE DEVICE INFORMATION WAS CONFIRMED AGAINST THE INFORMATION LISTED WITHIN GCH FROM THE TYVEK LID. THERE WAS NO PAPERWORK PROVIDED. DEVICE VISUAL INSPECTION: THE DEVICE IS USED WITH EXCESSIVE BLOOD ON THE HANDLE, FINGER-GRIP, SHAFT AND NOSE. THE SUCTION TUBING CONTAINS EXCESSIVE BLOOD. BLOOD AND OTHER BIOLOGICAL FLUIDS PRESENT ALONG THE INNER SHAFT. THERE IS AN ACCUMULATION OF EXCESSIVE ESCHAR BUILD-UP ON THE ELECTRODE, INSIDE THE HEAT SHRINK, AND INSIDE THE SUCTION OPENING, WHICH MAY COMPROMISE DEVICE PERFORMANCE, FIGURE # 1 THRU FIGURE # 4. THE HEAT SHRINK IS DAMAGED, MELTED, SCRATCHED AND SPLIT, BUT REMAINS ATTACHED TO THE ELECTRODE BLADE WHICH VISUALLY RELATES TO THE REPORTED COMPLAINT DESCRIPTION, ALL OTHER COMPONENTS APPEAR IN PLACE AND INTACT, FIGURES # 1 THRU FIGURE # 4. THE CORD AND PLUG CONNECTOR WAS CUT OFF FROM THE DEVICE WHICH IMPEDES A FURTHER FUNCTIONAL INSPECTION, FIGURE # 4. ADDITIONALLY, IT WAS FOUND THAT THE ELECTRODE INSULATION COATING IS DAMAGED, PEELING, FIGURE # 1 AND FIGURE # 2. THE DAMAGE TO THE DEVICE CORD RENDERS THE DEVICE INOPERABLE AND IMPEDES FUNCTIONAL INSPECTION. FUNCTIONAL INSPECTION: THE FUNCTIONAL INSPECTION WAS NOT PERFORMED BECAUSE THE CORD WAS CUT OFF FROM THE DEVICE WHICH RENDERS THE DEVICE INOPERABLE. LHR REVIEW: A REVIEW OF THE LHR FOR LOT # FL50908203 REVEALED THERE WERE NO PROBLEMS DURING MANUFACTURING THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT DESCRIPTION. INVESTIGATION CONCLUSION: COMPLAINT CONFIRMED: THE REPORTED ISSUE CONTAINED WITHIN GCH WAS VISUALLY CONFIRMED WITHIN THE LABORATORY ENVIRONMENT. INADEQUATE C LEANING AND USE OF THE ELECTRODE CAN CREATE TISSUE AND COAGULUM BUILDUP ON THE ELECTRODE AND INSIDE THE HEAT SHRINK. WHEN THIS OCCURS, THE RF ENERGY PATH MAY BE ALTERED SUCH THAT THE ENERGY IS DIRECTED TO THE TISSUE ON THE ELECTRODE, RATHER THAN TO THE PATIENT; IT IS PROBABLE THE HEAT SHRINK WILL DEGRADE. THIS COMPLAINT WILL BE TRACKED AND TRENDED IN GCH. REFERENCE DOCUMENTS: 42-10-1020 REV. H - WORK INSTRUCTIONS FOR COMPLAINT INVESTIGATIONS - DISPOSABLE DEVICES , 31-10-1369 REV. K - PRODUCT SPECIFICATION AND QUALITY PLAN - PLASMABLADE 3.0, 70-10-1452 REV. B - PEAK PLASMABLADE 3.0S - LOCKING MECHANISM - IFU 70-10-1429 REV. B - PULSAR II GENERATOR - OPERATORS MANUAL, 61-10-0017. REV. H - DEVICE BUTTON TACTILE TEST PROCEDURE TEST EQUIPMENT: THE FUNCTIONAL INSPECTION WAS NOT PERFORMED AS THE COMPLAINT WAS CONFIRMED VIA VISUAL INSPECTION; THEREFORE, NO TEST EQUIPMENT WAS UTILIZED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING ANALYSIS, IT WAS FOUND THAT THE ELECTRODE INSULATION COATING ON THE PLASMABLADE DEVICE WAS PEELING. THE ISSUE WAS DISCOVERED DURING ANALYSIS; THEREFORE NO PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688329 PLASMABLADE 3.0S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS210-030S FL50908203

    Patients

    Seq Age Sex Outcome Treatment
    1