BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 3.0S

    MDR report key: 6036183 · Received October 18, 2016

    Report

    Report Number
    1226420-2016-00156
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 19, 2016
    Report Date
    March 27, 2017
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4) PATIENT INFORMATION INCOMPLETE AND MISSING PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #701487537:BRIEF DESCRIPTION OF COMPLAINT: DURING USE IT WAS NOTICED THAT THE HEAT SHRINK HAD DETACHED FROM DEVICE AND HAD FALLEN ONTO THE FLOOR. SUCTION OF THE DEVICE WAS MAKING A WHISTLING NOISE AS IF TISSUE WAS LODGE INSIDE. AFTER THE CASE, WHEN CLEANING THE DEVICE FOR TURN THE BLACK COATING STARTED TO FLAKE OFF. INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) LHR REVIEW COMPLAINT DEVICE DETAILS: DEVICE NAME: PLASMABLADE¿ 3.0S PRODUCT NUMBER: PS210-030S LOT NUMBER: 0210971264 EXPIRATION DATE: 17-MAR-2019 QUANTITY RETURNED: 1 TESTING PERFORMED: DEVICE PACKAGING INSPECTION: ¿ ONE RETURNED PLASMABLADE¿ 3.0S DEVICE WITH LOCKING MECHANISM WAS RECEIVED INSIDE A CARDBOARD BOX WITH A BIOHAZARD BAG WITH MINIMAL PACKAGING TO FILL THE NEGATIVE SPACE. ¿ THE DISPLAY BOX WAS RETURNED; THE DEVICE INFORMATION WAS CONFIRMED AGAINST THE INFORMATION LISTED WITHIN GCH FROM THE DISPLAY BOX. ¿ THERE WAS NO PAPERWORK PROVIDED. DEVICE VISUAL INSPECTION: ¿ THE APPEARS CLEAN AND USED. ¿ THE ELECTRODE INSULATION COATING IS DAMAGED, FLAKED AND PEELING, WHICH VISUALLY RELATES TO THE REPORTED COMPLAINT DESCRIPTION, FIGURE # 1 THRU FIGURE # 4. ¿ THE HEAT SHRINK IS DETACHED FROM THE DEVICE AND WAS NOT RETURNED, WHICH VISUALLY RELATES TO THE REPORTED COMPLAINT DESCRIPTION, FIGURE # 3 AND FIGURE 4. ¿ THE SUCTION OPENING CONTAINS MINIMAL TISSUE AND COAGULUM BUILDUP, WHICH VISUALLY RELATES TO THE REPORTED COMPLAINT DESCRIPTION, FIGURE # 5 AND FIGURE # 6. ¿ THE DEVICE PLUG CONNECTOR SUPPLIER IS AMPHENOL. FUNCTIONAL INSPECTION: ¿ BOTH CUT AND COAG BUTTONS HAVE A DEFINITIVE TACTILE FEEL. ¿ THE DEVICE WAS SET-UP FOR USE WITH THE WHISPERATOR SUCTION MACHINE, CANISTER AND ASPIRATION TUBING AND ACTIVATED TO DETERMINE IF A WHISTLING NOISE COULD BE HEARD COMING FROM THE SUCTION TUBING. ¿ THE PLASMABLADE¿ 3.0S DEVICE WAS CONNECTED TO THE SUCTION MACHINE AND THERE WAS A STEADY FLOW OF AIR, SUCTION, COMING THROUGH THE SUCTION SHAFT OF THE DEVICE ¿ THERE WAS NO INDICATION OF A WHISTLING NOISE HEARD COMING FROM THE DEVICE OR THE SUCTION TUBING DURING THE COMPLAINT INVESTIGATION. LHR REVIEW: A REVIEW OF THE LHR FOR LOT # 0210971264 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. HOWEVER, THE COMPLAINT IS NOT CONFIRMED FOR THE WHISTLING NOISE COMING FROM THE DEVICE SUCTION TUBING. 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 31-10-1365 REV. N - AEX¿ - PRODUCT SPECIFICATION AND QUALITY PLAN 70-10-1455 REV. F - AEX¿ GENERATOR - OPERATOR¿S MANUAL 61-10-0017 REV. H - DEVICE BUTTON TACTILE TEST PROCEDURE 61-10-0007 REV. N - DEVICE RESISTANCE TESTING TEST EQUIPMENT: EQP # EQP - NAME - MANUFACTURER (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING A BREAST ONCOLOGY CASE, THE HEAT SHRINK DETACHED FROM THE PLASMABLADE DEVICE. THERE WAS NO IMPACT TO THE PATIENT. AFTER THE CASE WAS COMPLETED, IT WAS ALSO REPORTED THE DEVICE TIP COATING WAS FLAKING.

    Description of Event or Problem · 1

    DURING A BREAST ONCOLOGY CASE, THE HEAT SHRINK DETACHED FROM THE PLASMABLADE DEVICE. THERE WAS NO IMPACT TO THE PATIENT. AFTER THE CASE WAS COMPLETED, IT WAS ALSO REPORTED THE DEVICE TIP COATING WAS FLAKING.

    Description of Event or Problem · 1

    DURING A BREAST ONCOLOGY CASE, THE HEAT SHRINK DETACHED FROM THE PLASMABLADE DEVICE. THERE WAS NO IMPACT TO THE PATIENT. AFTER THE CASE WAS COMPLETED, IT WAS ALSO REPORTED THE DEVICE TIP COATING WAS FLAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687875 PLASMABLADE 3.0S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS210-030S 0210971264

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR