BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC ADVANCED ENERGY, LLC

    MDR report key: 6096174 · Received November 11, 2016

    Report

    Report Number
    1226420-2016-00174
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 4, 2016
    Report Date
    March 28, 2017
    Manufacturer
    180 INTERNATIONAL DRIVE
    Product Code
    GEI
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4) :BRIEF DESCRIPTION OF COMPLAINT: PART OF THE PLASMABLADE DEVICE TIP MELTED DURING USE. INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) LHR REVIEW COMPLAINT DEVICE DETAILS: DEVICE NAME: PLASMABLADE" 3.0S PRODUCT NUMBER: PS210-030S LOT NUMBER: 0211057887 EXPIRATION DATE: 26-APR-2019 QUANTITY RETURNED: 1 TESTING PERFORMED: DEVICE PACKAGING INSPECTION: " ONE RETURNED PLASMABLADE" 3.0S DEVICE WITH LOCKING MECHANISM WAS RECEIVED INSIDE A CARDBOARD BOX WITHIN A BIOHAZARD BAG WITH BUBBLE WRAP TO FILL THE NEGATIVE SPACE. " THE PLASTIC TRAY, DISPLAY BOX, AND THE TYVEK® LID WERE RETURNED; THE DEVICE INFORMATION WAS CONFIRMED AGAINST THE INFORMATION LISTED WITHIN GCH FROM THE DISPLAY BOX AND THE TYVEK® LID. " THERE WAS A PRINTED RGA EMAIL PROVIDED. DEVICE VISUAL INSPECTION: " THE DEVICE APPEARS USED WITH EXCESSIVE AMOUNTS OF DRIED BLOOD ON BODY, HANDLE, CORD SHAFT AND NOSE. " THERE IS BLOOD AND OTHER BIOLOGICAL FLUIDS PRESENT ALONG THE INNER SHAFT. " THE ELECTRODE INSULATION COATING IS DAMAGED, FLAKED AND PEELING; FIGURE # 1 THRU FIGURE # 4. " THE HEAT SHRINK IS DAMAGED BUT REMAINS ATTACHED TO THE ELECTRODE BLADE, WHICH VISUALLY RELATES TO THE REPORTED COMPLAINT DESCRIPTION, FIGURE # 3 AND FIGURE 4. " THE SUCTION OPENING CONTAINS EXCESSIVE TISSUE AND COAGULUM BUILDUP, WHICH VISUALLY RELATES TO THE REPORTED COMPLAINT DESCRIPTION, FIGURE # 5 AND FIGURE # 6. " THE DAMAGE TO THE HEAT SHRINK AND THE ELECTRODE INSULATION COATING IS CONSISTENT WITH INSUFFICIENT CLEANING AND USE OF THE DEVICE. " THE DEVICE PLUG CONNECTOR SUPPLIER IS AMPHENOL. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION NOT PERFORMED BECAUSE THE COMPLAINT WAS CONFIRMED VIA VISUAL INSPECTION LHR REVIEW: A REVIEW OF THE LHR FOR LOT # 0211057887 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. INSUFFICIENT CLEANING OF THE ELECTRODE DURING USE 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 AND THE ELECTRODE INSULATION COATING CAN BE COMPROMISED. THIS COMPLAINT WILL BE TRACKED AND TRENDED IN GCH. ADDITIONALLY, IT WAS FOUND THAT THE ELECTRODE INSULATION COATING IS DAMAGED, FLAKED AND PEELING. REFERENCE DOCUMENTS: (B)(4) REV. H - WORK INSTRUCTIONS FOR COMPLAINT INVESTIGATIONS - DISPOSABLE DEVICES (B)(4) REV. K - PRODUCT SPECIFICATION AND QUALITY PLAN - PLASMABLADE" (B)(4) REV. B - PEAK PLASMABLADE" 3.0S - LOCKING MECHANISM - IFU (B)(4) REV. B - PULSAR" II GENERATOR - OPERATORS MANUAL (B)(4) 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. PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4).

    Description of Event or Problem · 1

    FAILURE FOUND DURING ANALYSIS THAT THE ELECTRODE INSULATION COATING WAS FLAKING AND PEELING ON THE PLASMABLADE DEVICE. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    FAILURE FOUND DURING ANALYSIS THAT THE ELECTRODE INSULATION COATING WAS FLAKING AND PEELING ON THE PLASMABLADE DEVICE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747089 MEDTRONIC ADVANCED ENERGY, LLC ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI 180 INTERNATIONAL DRIVE PS210-030S 0211057887

    Patients

    Seq Age Sex Outcome Treatment
    1