BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 4.0

    MDR report key: 3940503 · Received July 17, 2014

    Report

    Report Number
    1226420-2014-00049
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 25, 2014
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    K073057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4). EVALUATION CODE (METHOD): PRODUCT RETURNED FOR ANALYSIS AND ANALYSIS IS CURRENTLY UNDERWAY. (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(6) TESTING PERFORMED: DEVICE PACKAGING INSPECTION: THE PLASMABLADE 4.0 WAS RECEIVED INSIDE A BUBBLE WRAP MAILER ENVELOPE WITHIN A SINGLE PLASTIC BAG WITH NO PACKAGING TO FILL THE NEGATIVE SPACE. TYVEK LID INCLUDED WITH NO OTHER ORIGINAL PACKAGING INCLUDED. DEVICE INFORMATION MATCHES THE PRODUCT EVENT PAGE LISTED IN GCH. EMAIL WITH RGA INFORMATION PRINT OUT ENCLOSED DEVICE VISUAL INSPECTION: THE DEVICE APPEARS UNUSED WITH NO VISIBLE BLOOD OR TISSUE NOTED. ELECTRODE HAS VISIBLE DAMAGE AS EVIDENCED BY A NICK OF THE BLADE COATING ON THE FRONT SIDE. THE BLADE COATING IS SCRATCHED SO THAT THE MISSING BLADE COATING IS PEELED BACK ON THE ELECTRODE, FIGURE # 1 AND FIGURE # 2. ALL COMPONENTS APPEAR IN PLACE AND INTACT. BOTH CUT AND COAG BUTTONS HAVE A DEFINITIVE TACTILE FEEL. FUNCTIONAL INSPECTION: NOT APPLICABLE AS THE COMPLAINT IS NOT RELATED TO ACTIVATION OF THE DEVICE. LHR REVIEW: (B)(4).

    Description of Event or Problem · 1

    DURING SURGERY-SET UP A PLASMABLADE 4.0 DEVICE WAS OPENED AND IT WAS NOTICED THAT THE TIP HAD A SMALL PIECE OF THE INSULATION COATING THAT CHIPPED OFF. ANOTHER DEVICE WAS OPENED AND UTILIZED WITHOUT FURTHER INCIDENT. NO PATIENT IMPACT.

    Description of Event or Problem · 1

    DURING SURGERY-SET UP A PLASMABLADE 4.0 DEVICE WAS OPENED AND IT WAS NOTICED THAT THE TIP HAD A SMALL PIECE OF THE INSULATION COATING THAT CHIPPED OFF. ANOTHER DEVICE WAS OPENED AND UTILIZED WITHOUT FURTHER INCIDENT. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419414 PLASMABLADE 4.0 ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC PS200-040E 0207823386

    Patients

    Seq Age Sex Outcome Treatment
    1