BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 3.0 WIDE SPATULA

    MDR report key: 3934842 · Received July 15, 2014

    Report

    Report Number
    1226420-2014-00045
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    DWG
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INVESTIGATION PLAN: VISUAL INSPECTION, FUNCTIONAL INSPECTION (IF APPLICABLE), LHR REVIEW TESTING PERFORMED: COMPLAINT DEVICE DETAILS: OBTAIN INFORMATION FROM THE RETURNED DEVICE DEVICE: PLASMABLADE¿ 3.0S PRODUCT CODE (SKU): UNKNOWN SERIAL / LOT NUMBER: UNKNOWN EXPIRATION DATE: UNKNOWN QUANTITY RETURNED: 1. ANY DISCREPANCIES IDENTIFIED BETWEEN DEVICE INFO OBTAINED FROM RETURNED PRODUCT AND DEVICE INFO POPULATED IN PRODUCT LINE ITEMS SECTION IN (B)(6): YES. IF YES, DESCRIBE: THE DEVICE INFORMATION WAS OBTAINED FROM (B)(6) AND IS LISTED BELOW SINCE THERE WAS NO ORIGINAL PACKAGING RETURNED, OTHER THAN THE PLASTIC TRAY, THEREFORE IT IS NOT POSSIBLE TO CONFIRM THE DEVICE THAT WAS SENT BACK AS THE REPORTED COMPLAINT DEVICE. PRODUCT CODE (SKU): PS210-030S SERIAL / LOT NUMBER: (B)(4) EXPIRATION DATE: 2017-04-01 VISUAL INSPECTION (PACKAGING): SHIPPING CONTAINER: YES. PACKAGING TO FILL NEGATIVE SPACE: NO. IF YES, DESCRIBE: DEVICE SAFETY PACKAGING: NO ADDITIONAL PAPERWORK INCLUDED: YES. IF YES, DESCRIBE: LOT # FL50797380 HANDWRITTEN ON PAPER TAPE WRAPPED AROUND PLASTIC TRAY. VISUAL INSPECTION (PRODUCT): (MUST BE FILLED OUT FOR EACH DEVICE RETURNED) EVIDENCE OF USE: YES. IF YES, DESCRIBE: BLOOD ON BODY, SHAFT AND CORD EXCESSIVE TISSUE BUILD-UP INSIDE THE SUCTION OPENING OF THE FINGER GRIP, FIGURE # 4. BLOOD AND OTHER BIOLOGICAL FLUIDS OOZING FROM TELESCOPING SHAFT WHEN EXTENDED. DEVICE CORD AND SUCTION TUBING HAS BEEN CUT FROM DEVICE, FIGURE # 1. ESCHAR BUILD-UP AND CHARRING OF THE ELECTRODE. HEAT SHRINK DETACHED FROM THE DEVICE, FIGURE # 2 AND FIGURE # 3. EVIDENCE OF DAMAGE: YES. IF YES, DESCRIBE: DEVICE CORD AND SUCTION TUBING HAS BEEN CUT FROM DEVICE HEAT SHRINK DETACHED FROM THE DEVICE BUTTON TACTILE FEEL: YES. IF NO, DESCRIBE: VISUAL SIGNS RELATED COMPLAINT DESCRIPTION: YES. IF YES, DESCRIBE: HEAT SHRINK DETACHED FROM THE DEVICE FUNCTIONAL INSPECTION: (IF INSPECTION PERFORMED, MUST BE FILLED OUT FOR EACH DEVICE TESTED) FUNCTIONAL INSPECTION IS NOT POSSIBLE SINCE THE DEVICE CORD HAS BEEN CUT FROM THE DEVICE WHICH RENDERS THE DEVICE INOPERABLE. LHR REVIEW: [LOT# (OF RETURNED PRODUCT OR WHAT IS POPULATED AS THE LOT# IN GCH), ANY DEVIATIONS, FAILURES, SCRAP, ETC. PERTAINING TO COMPLAINT DESCRIPTION] A REVIEW OF THE LHR FOR THE PLASMABLADE¿ 3.0S ¿ LOT # FL50797380 - REVEALED THERE WERE NO PROBLEMS DURING MANUFACTURING THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. INVESTIGATION CONCLUSION: (COMPLAINT CONFIRMED/NOT CONFIRMED, SUMMARY OF FINDINGS, LIKELY CAUSE OF FAILURE, POTENTIAL CAUSE OF REPORTED COMPLAINT, RECOMMENDATIONS) THE COMPLAINT IS CONFIRMED AND FOUND TO BE OUT OF OUT OF PRODUCT SPECIFICATIONS FOR ¿HEAT SHRINK DETACHED¿ ISSUE THAT WAS REPORTED IN THE COMPLAINT DESCRIPTION. VISUAL INSPECTION CONFIRMED THE HEAT SHRINK WAS DETACHED FROM THE ELECTRODE AS WELL AS THERE WAS AN ACCUMULATION OF TISSUE BUILD-UP IN THE SUCTION OPENING OF THE FINGER GRIP CAUSING THE DEVICE TO BECOME CLOGGED. THE FINGER GRIP INCORPORATES A SUCTION LUMEN FOR THE EVACUATION OF SMOKE AND FLUIDS. THE LIKELY CAUSE OF THE FAILURE IS USER MISUSE BY ALLOWING THE SUCTION OPENING TO BECOME CLOGGED WITH AN EXCESSIVE BUILD-UP OF TISSUE RESULTING IN THE OVERHEATING AND MELTING OF THE HEAT SHRINK. THE RF ENERGY IS AFFECTED BY THE CLOG OR GUNK BUILD-UP AND CAUSES A CHANGE TO THE ELECTRICAL PATH CAUSING THE ENERGY TO BE DIRECTED TO THE TISSUE ATTACHED TO THE DEVICE (IN THIS CASE NEAR THE HEATSHRINK) RATHER THAN TO THE PATIENT. WHEN THE ENERGY PATH IS DIRECTED TO THE TISSUE ON THE HEATSHRINK, THE COMPONENT EXPERIENCES HIGH TEMPERATURE AND OVER TIME, IT IS POSSIBLE FOR THE HEATSHRINK TO DEGRADE. THE COMPLAINT WILL BE TRACKED AND TRENDED IN GCH. IFU ¿ PRECAUTIONS: DURING SURGERY: NOTE: ESCHAR BUILDUP ON THE TIP CAN BE REMOVED MANUALLY WITH GLOVED FINGERS OR GAUZE PADS, OR BY INSERTING THE TIP INTO THE SLOT AT THE FRONT OF THE HOLSTER AND DRAWING THE DEVICE BACKWARDS THROUGH THE SLOT. INSPECT THE DEVICE FOR ANY SIGNS OF DAMAGE AFTER CLEANING. ACTIVATION OF THE HANDPIECE SIMULTANEOUSLY WHILE ASPIRATING FLUID MAY ALTER THE PATH OF ELECTRICAL ENERGY AWAY FROM TARGET TISSUE. REFERENCED DOCUMENTS: (LIST DOCUMENT NUMBER, TITLE, AND REVISION FOR ALL DOCUMENTS UTILIZED TO PERFORM COMPLAINT INVESTIGATION) (B)(4). DEVICE BUTTON TACTILE TEST PROCEDURE TEST EQUIPMENT UTILIZED: (PLEASE DELETE THE EQUIPMENT NOT UTILIZED DURING THE COMPLAINT INVESTIGATION, LEAVING A LISTING OF THE EQUIPMENT UTILIZED TO PERFORM THE INVESTIGATION) EQP # EQP - NAME - MANUFACTURER N/A NO EQUIPMENT UTILIZED. (B)(4).

    Description of Event or Problem · 1

    DURING A SPINE PROCEDURE THE PLASMABLADE WAS CLEANED BY PUTTING THE DEVICE ELECTRODE THROUGH THE CLEANING SLOT ON THE HOLSTER AND THE HEAT SHRINK AT THE BASE OF THE DEVICE DETACHED AND FELL ONTO THE OR FLOOR. AT THE TIME OF THE DETACHMENT THE DEVICE HAD BEEN USED FOR APPROXIMATELY 2 HOURS ON SETTINGS CUT 6, COAG 8, AND THE SURGEON ALMOST COMPLETE WITH THE CAUTERY PORTION OF THE SURGERY THEREFORE USE OF THE PLASMABLADE WAS DISCONTINUED. NO ASSOCIATED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414148 PLASMABLADE 3.0 WIDE SPATULA ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY (SALIENT) PS210-030S FL50797380

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR