BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 4.0

    MDR report key: 6059848 · Received October 27, 2016

    Report

    Report Number
    1226420-2016-00164
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 28, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K073057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):BRIEF DESCRIPTION OF COMPLAINT: AN E-1 ERROR WAS DISPLAYED, WHICH CLEARED AFTER RELEASING THE COAG BUTTON ON THE HANDPIECE. INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) LHR REVIEW COMPLAINT DEVICE DETAILS: DEVICE NAME: PLASMABLADE 4.0, PRODUCT NUMBER: PS200-040, LOT NUMBER: 0210779036, EXPIRATION DATE: 08-FEB-2019, QUANTITY RETURNED: 1 TESTING PERFORMED: DEVICE PACKAGING INSPECTION: ONE RETURNED PLASMABLADE 4.0 DEVICE WAS RECEIVED INSIDE A (B)(6) SHIPPER BOX, THEN WITHIN A SMALLER (B)(6) SHIPPER BOX WITHIN TWO BIOHAZARD BAGS WITH NO PACKAGING TO FILL THE NEGATIVE SPACE. NO ORIGINAL PACKAGING RETURNED; THEREFORE, 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. THERE WAS NO PAPERWORK PROVIDED. DEVICE VISUAL INSPECTION: THE DEVICE IS USED WITH DRIED BLOOD ON BODY, HANDLE, SHAFT AND CORD. THE DEVICE CORD AND PLUG CONNECTOR HAVE BEEN CUT OFF FROM THE DEVICE WHICH RENDERS THE DEVICE INOPERABLE AND IMPEDES A FUNCTIONAL INSPECTION, FIGURE # 1 AND FIGURE # 2. ADDITIONALLY, IT WAS FOUND THAT THE ELECTRODE INSULATION COATING IS PEELING AND THE BLACK HEAT SHRINK IS SCRATCHED, MELTED AND SPLIT. THERE ARE EXCESSIVE AMOUNTS OF ESCHAR, TISSUE AND COAGULUM BUILDUP PRESENT ON THE ELECTRODE AND INSIDE THE HEAT SHRINK, WHICH IS CONSISTENT WITH IMPROPER CLEANING AND USE AND CAN CAUSE DIMINISHED DEVICE PERFORMANCE, FIGURE # 3 THRU FIGURE # 8. THERE ARE NO VISUAL SIGNS THAT RELATE TO THE REPORTED COMPLAINT DESCRIPTION. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS NOT PERFORMED DUE TO A CUT CORD, WHICH PREVENTED FUNCTIONAL TESTING LHR REVIEW: A REVIEW OF THE LHR FOR LOT # 0210779036 REVEALED THERE WERE NO PROBLEMS DURING MANUFACTURING THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT DESCRIPTION. INVESTIGATION CONCLUSION: COMPLAINT NOT CONFIRMED: THE REPORTED ISSUE CONTAINED WITHIN GCH WAS NOT DUPLICATED IN THE LABORATORY ENVIRONMENT. THE DEVICE WAS UNABLE TO BE INVESTIGATED FOR THE REPORTED ISSUE BECAUSE THE DEVICE PLUG CONNECTOR WAS CUT OFF FROM THE DEVICE. THIS COMPLAINT WILL BE TRACKED AND TRENDED WITHIN GCH. ADDITIONALLY, IT WAS FOUND THAT THE ELECTRODE INSULATION COATING IS PEELING AND THE HEAT SHRINK IS MELTED AND SPLIT. INADEQUATE CLEANING 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 AND THE ELECTRODE INSULATION COATING MAY BE COMPROMISED. REFERENCE DOCUMENTS: 42-10-1020 REV. H - WORK INSTRUCTIONS FOR COMPLAINT INVESTIGATIONS - DISPOSABLE DEVICES, 31-10-1368 REV. H - PRODUCT SPECIFICATION AND QUALITY PLAN ¿ PLASMABLADE 4.0, 70-10-1444 REV. A - PEAK PLASMABLADE 4.0 ¿ IFU, 61-10-0017 REV. H - DEVICE BUTTON TACTILE TEST PROCEDURE TEST EQUIPMENT: THE FUNCTIONAL INSPECTION PORTION OF THIS COMPLAINT WAS NOT PERFORMED; 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 FOUND DURING ANALYSIS; THEREFORE PATIENT DEMOGRAPHIC INFORMATION WAS NOT REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711317 PLASMABLADE 4.0 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS200-040 0210779036

    Patients

    Seq Age Sex Outcome Treatment
    1