BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 3.0S

    MDR report key: 5716803 · Received June 10, 2016

    Report

    Report Number
    1226420-2016-00077
    Event Type
    Malfunction
    Date Received
    June 10, 2016
    Date of Event
    May 12, 2016
    Report Date
    July 7, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). 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 ANALYSIS #(B)(4):BRIEF DESCRIPTION OF COMPLAINT: DURING USE THE SURGEON WAS UTILIZING METAL FORCEPS TO INCREASE THE COAGULATION, WHICH RESULTED IN A QUICK BURST OF FLAME FROM THE HANDPIECE RESULTING IN A BURNT O THE SURGEON¿S GLOVE. THE HEAT SHRINK WAS ALSO NOTED AS BEING SPLIT, BUT REMAINED ATTACHED TO THE DEVICE TIP. THERE WERE NOT PATIENT OR OPERATOR INJURIES THAT OCCURRED. INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) LHR REVIEW COMPLAINT DEVICE DETAILS: DEVICE NAME: PLASMABLADE¿ 3.0S PRODUCT NUMBER: PS210-030S LOT NUMBER: UNKNOWN EXPIRATION DATE: UNKNOWN QUANTITY RETURNED: 1 TESTING PERFORMED: DEVICE PACKAGING INSPECTION: ONE PLASMABLADE¿ 3.0S DEVICE WITH LOCKING MECHANISM WAS RECEIVED INSIDE A PLASTIC MAILER ENVELOPE WITHIN A BIOHAZARD BAG WITH NO PACKAGING TO FILL THE NEGATIVE SPACE. PRODUCT RETURN DISCREPANCY; THE PRODUCT RETURNED LOT NUMBER DOES NOT MATCH THE POPULATED PLI INFORMATION WITHIN GCH. NO ORIGINAL PACKAGING WAS RETURNED THEREFORE THE EEPROM VERIFICATION READER WAS UTILIZED TO OBTAIN THE DEVICE INFORMATION HANDPIECE TYPE: PLASMABLADE¿ 3.0S, LOT NUMBER: FL50914005. BECAUSE THE DEVICE LOT NUMBER AND EXPIRATION DATE IS LISTED AS UNKNOWN WITHIN GCH IT IS NEITHER POSSIBLE TO CONFIRM THE DEVICE INFORMATION AGAINST THE INFORMATION LISTED WITHIN GCH NOR CONFIRM THE DEVICE THAT WAS SENT BACK AS THE REPORTED COMPLAINT DEVICE. NO PAPERWORK WAS PROVIDED. DEVICE VISUAL INSPECTION: DEVICE IS USED WITH BLOOD ON HANDLE, FINGER GRIP, LOCKING MECHANISM, SUCTION TUBING LINE AND ELECTRODE. BLOOD AND OTHER BIOLOGICAL FLUIDS PRESENT ALONG THE INNER SHAFT. EXCESSIVE ESCHAR BUILD-UP ON THE ELECTRODE, FIGURE # 1 AND FIGURE # 2. THE HEAT SHRINK IS DAMAGED, MELTED AND SPLIT, BUT REMAINS ATTACHED TO THE ELECTRODE BLADE, CONTAINS TISSUE AND COAGULUM BUILD-UP WHICH VISUALLY RELATES TO THE REPORTED COMPLAINT DESCRIPTION, FIGURE # 1 THRU FIGURE # 4. THE SUCTION OPENING CONTAINS EXCESSIVE BLOOD, TISSUE AND COAGULUM BUILD-UP, FIGURE # 3 AND FIGURE # 4. THE IFU (INSTRUCTIONS FOR USE) LISTS WARNINGS FOR SAFE AND PROPER USE OF THE PLASMABLADE¿ DEVICE: READ ALL IFU INSTRUCTIONS CAREFULLY. FAILURE TO COMPLY MAY LEAD TO ELECTRICAL OR THERMAL INJURY, OR CAUSE DEVICE MALFUNCTION. UNLESS THE PRODUCT IS BEING USED TO SPOT COAGULATE A VESSEL, IT IS RECOMMENDED TO KEEP THE ELECTRODE TIP IN MOTION WHILE ACTIVATED TO AVOID EXCESSIVE ESCHAR BUILDUP. EXCESSIVE ESCHAR BUILDUP CAN COMPROMISE DEVICE PERFORMANCE. AN ELECTROSURGICAL DEVICE MAY PROVIDE AN IGNITION SOURCE DUE TO SPARKING AND HEATING. DO NOT CONTACT METAL OBJECTS AND INSTRUMENTS WITH THE PEAK PLASMABLADE® WHILE POWER IS BEING APPLIED AS UNINTENDED TISSUE DAMAGE A ND ELECTRODE TIP DAMAGE COULD OCCUR. ENSURE THAT ONLY THE ACTIVE TIP OF THE DEVICE IS IN CONTACT WITH THE PATIENT DURING USE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION NOT PERFORMED BECAUSE THE COMPLAINT WAS CONFIRMED VIA VISUAL INSPECTION. LHR REVIEW: A REVIEW OF THE LHR FOR LOT # FL50914005 REVEALED THERE WERE NO PROBLEMS DURING MANUFACTURING THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT DESCRIPTION. INVESTIGATION CONCLUSION: COMPLAINT CONFIRMED: THE REPORTED ISSUE OF ¿HEAT SHRINK DAMAGE¿ CONTAINED WITHIN GCH WAS VISUALLY CONFIRMED IN THE LABORATORY ENVIRONMENT AND IS CONSISTENT WITH INSUFFICIENT CLEANING OF THE ELECTRODE DURING USE. THE ESCHAR, TISSUE AND COAGULUM BUILD-UP PRESENT ON THE ELECTRODE, INSIDE THE HEAT SHRINK AND INSIDE THE SUCTION OPENING RESULTS IN THE OVERHEATING AND MELTING OF THE HEAT SHRINK. THE RADIOFREQUENCY (RF) ENERGY IS AFFECTED BY THE TISSUE BUILD-UP AND CAUSES A CHANGE TO THE ELECTRICAL PATH CAUSING THE ENERGY TO BE DIRECTED TO THE TISSUE ATTACHED TO THE DEVICE RATHER THAN TO THE PATIENT. WHEN THE ENERGY PATH IS DIRECTED TO THE TISSUE ON THE HEAT SHRINK, THE COMPONENT EXPERIENCES HIGH TEMPERATURES AND OVER TIME, IT IS POSSIBLE FOR THE HEAT SHRINK TO DEGRADE AND COMPROMISE THE ELECTRODE INSULATION COATING. THIS COMPLAINT WILL BE TRACKED AND TRENDED IN (B)(4). THE COMPLAINT CANNOT BE CONFIRMED FOR THE ¿FLAME - FIRE¿ ISSUE DUE TO SAFETY CONCERNS AS ¿THE SURGEON WAS USING THE HANDPIECE IN CONJUNCTION WITH METAL FORCEPS¿ WHICH IS NOT RECOMMENDED PER THE IFU AND SUGGESTS MISUSE. THE DEVICE HEAT SHRINK IS MELTED AND SPLIT WHICH RENDERS THE DEVICE NOT SUITABLE FOR SAFE USE. THE HEAT SHRINK IS USED FOR THE INSULATION OF ELECTRICAL ENERGY BETWEEN THE USER AND THE CONDUCTING BLADE/SHAFT THEREFORE IS WOULD NOT BE SAFE TO CONNECT THE DEVICE INTO THE GENERATOR AND ACTIVATE IT AT THE SPECIFICATION REQUIREMENT SETTINGS FOR FUNCTIONAL TESTING. REFERENCE DOCUMENTS: 42-10-1020 REV. H ¿ WORK INSTRUCTIONS FOR COMPLAINT INVESTIGATIONS ¿ DISPOSABLE DEVICES 31-10-1369 REV. J ¿ PRODUCT SPECIFICATION AND QUALITY PLAN ¿ PLASMABLADE¿ 3.0 70-10-1452 REV. B ¿ PEAK PLASMABLADE® 3.0S - LOCKING MECHANISM ¿ IFU 61-10-0017 REV. H ¿ DEVICE BUTTON TACTILE TEST PROCEDURE TEST EQUIPMENT: 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.

    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 BILATERAL MASTECTOMY, THE SURGEON WAS USING A PLASMABLADE DEVICE IN CONJUNCTION WITH METAL FORCEPS AND REPORTED A QUICK BURST OF FIRE FROM THE DEVICE TIP TO THE SURGEON'S GLOVE. THERE WAS NO INJURY TO THE SURGEON AND NO INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    DURING A BILATERAL MASTECTOMY, THE SURGEON WAS USING A PLASMABLADE DEVICE IN CONJUNCTION WITH METAL FORCEPS AND REPORTED A QUICK BURST OF FIRE FROM THE DEVICE TIP TO THE SURGEON'S GLOVE. THERE WAS NO INJURY TO THE SURGEON AND NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371366 PLASMABLADE 3.0S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS210-030S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1