BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TNA

    MDR report key: 3143389 · Received June 3, 2013

    Report

    Report Number
    1226420-2013-00110
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT (B)(4) INVESTIGATION PLAN: VISUAL INSPECTION DOCUMENTATION REVIEW - LHR TESTING PERFORMED: DEVICE: PLASMABLADE TNA - ADENOID TIP PRODUCT SKU: (B)(4) - BATCH # 56902 MDT RGA NUMBER: (B)(4) POR EXPIRATION DATE: QUANTITY RETURNED: 1 ¿ ADENOID TIP ¿ NO DEVICE HANDLE ADENOID TIP RECEIVED IN A TRASH BAG BOX. NO PACKING PEANUTS OR BUBBLE WRAP TO FILL THE NEGATIVE SPACE. RECEIVED INSIDE ORIGINAL POUCH AND INSIDE A SINGLE BIOHAZARD BAG NO ORIGINAL PACKAGING INCLUDED. VISUAL INSPECTION: ADENOID TIP APPEARS UNUSED WITH NO BLOOD OR TISSUE NOTED. SHAFT PULLED BACK FROM THE FINGER GRIP. APPEARS THAT THERE IS AN INEFFICIENT AMOUNT OF GLUE ON SHAFT AND FINGER GRIP. FUNCTIONAL INSPECTION: UNABLE TO PERFORM FUNCTIONAL TESTING THE DEVICE HANDLE WAS NOT INCLUDED IN THE PRODUCT RETURN. INVESTIGATION CONCLUSION: THE COMPLAINT HAS BEEN CONFIRMED AND FOUND TO BE OUT OF SPECIFICATION. FROM THE INVESTIGATION RESULTS IT CAN BE CONCLUDED THAT THERE WERE TWO FAILURES THAT RESULTED FROM THE MANUFACTURING PROCESS OF THE ADENOID TIP IN THIS PRODUCT EVENT. FIRST, THE PLACEMENT OF THE TWO SPOT WELDS ON THE CONNECTOR AND SHAFT ARE SIDE BY SIDE AND NOT ON THE TOP AS PER THE MANUFACTURING PROCESS INSTRUCTION (MPI-00005 REV.B) THERE SHOULD BE TWO SPOT WELDS ON THE TOP OF THE CONNECTOR AND THE SHAFT, ILLUSTRATES A GOOD SPOT WELD AND FROM THE COMPLAINT INVESTIGATION ILLUSTRATES THAT THE SPOT WELDS ARE NOT ON THE TOP THEY ARE SIDE BY SIDE. IT CAN BE CONCLUDED THAT THE IMPROPER PLACEMENT OF THE SPOT WELDS FROM THE MANUFACTURING PROCESS RESULTED IN THIS FAILURE. SECOND, THE UV LOCTITE SHOULD BE SPREAD DOWN UNTIL IT REACHES OR PASSES THE TOP OF THE VERTICAL INDENTATION ON THE FINGER GRIP AND THEN CURED UNDER UV LAMP. THERE CLEARLY IS AN INADEQUATE AMOUNT OF UV LOCTITE AS WELL AS IMPROPER APPLICATION SINCE IT DOES NOT EXTEND DOWN OR PASS THE VERTICAL INDENTATION ON THE FINGER GRIP. AS NOTED IN MPI-00005 REV.B AND FROM THE COMPLAINT THERE WAS AN IMPROPER APPLICATION OF THE UV LOCTITE. IT CAN BE CONCLUDED THAT THERE WAS AN INADEQUATE AMOUNT OF UV LOCTITE THAT WAS APPLIED AS WELL AS IMPROPER APPLICATION IN THE MANUFACTURING PROCESS THAT RESULTED IN THIS FAILURE. (B)(4).

    Description of Event or Problem · 1

    ADENOID TIP WAS FORMED FOR PATIENT ACCESS AND THE TIP 'S INSULATION SEPARATED FROM THE HUB. INSULATION SEPARATED FROM THE GREY HUB DISTAL FROM THE ADENOID WIRE. THE ADENOID TIP WAS SITTING AND SUBMERGED IN A BASIN OF SALINE BEFORE BEING SEATED ON THE WAND. IT SEPARATED AND WAS NEVER USED ON THE PATIENT. NO PATIENT IMPACT AS ANOTHER ADENOID TIP WAS USED TO COMPLETE THE ADENOIDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244741 PLASMABLADE TNA ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC PS300-002E 0206315570

    Patients

    Seq Age Sex Outcome Treatment
    1 00008 YR