BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE PS300-002 4PK TNA

    MDR report key: 5571278 · Received April 12, 2016

    Report

    Report Number
    1226420-2016-00035
    Event Type
    Malfunction
    Date Received
    April 12, 2016
    Date of Event
    February 10, 2016
    Report Date
    March 13, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) LHR REVIEW COMPLAINT DEVICE DETAILS: (OBTAIN INFORMATION FROM THE PRODUCT LINE ITEMS IN GCH) PLEASE NOTE IF THERE ARE ANY DISCREPANCIES BETWEEN THE RETURNED DEVICE(S), AND THE DEVICE(S) LISTED WITHIN GCH. DEVICE NAME: PLASMABLADE TNA PRODUCT NUMBER: PS300-002 LOT NUMBER: 0210427425 EXPIRATION DATE: 15-NOV-2018 QUANTITY RETURNED: 8 TESTING PERFORMED: VISUAL INSPECTION: (DEVICE VISUAL INSPECTION MUST BE FILLED OUT FOR EACH DEVICE RETURNED) DEVICE PACKAGING INSPECTION: TWO RETURNED PLASMABLADE TNA FOUR-PACK BOXES CONTAINING EIGHT DEVICES RECEIVED INSIDE A (B)(6) SHIPPER BOX NOT WITHIN A BIOHAZARD BAGS WITH NO PACKAGING TO FILL THE NEGATIVE SPACE. ORIGINAL (B)(6) SHIPPER BOX WAS NOT RETURNED. PLASTIC TRAYS AND TYVEK LIDS RETURNED; THE DEVICE INFORMATION WAS CONFIRMED AGAINST THE INFORMATION LISTED WITHIN GCH. DEVICES WERE LABELED AS DEVICE # 1 THRU DEVICE # 8 FOR TRACEABILITY. NO PAPERWORK WAS INCLUDED. DEVICE VISUAL INSPECTION: ORIGINAL (B)(6) SHIPPER BOX WAS NOT RETURNED FOR INVESTIGATION WHICH IMPEDES FUNCTIONAL INSPECTION OF A POSSIBLE TRANSIT DAMAGE EVENT THAT MAY HAVE CONTRIBUTED TO THE DAMAGE THE DEVICES SUFFERED. ALL EIGHT DEVICES WERE LABELLED AS DEVICE # 1 THRU DEVICE # 8 FOR TRACEABILITY. TWO FOUR-PACK DISPLAY BOXES CONTAINING FOUR DEVICES EACH FOR A TOTAL OF EIGHT RETURNED DEVICES EXHIBIT NO EVIDENCE OF DAMAGE TO THE DISPLAY BOXES. ALL EIGHT DEVICES WERE WITHIN A PARTIALLY SEALED PLASTIC TRAY AND EXHIBIT NO INDICATION OF USE. ALL COMPONENTS APPEAR IN PLACE, INTACT WITH MAJOR DAMAGE TO THE TYVEK LID SEALS AS THE TYVEK LID SEALS LOST ADHESION OF THE PVC ADHESIVE BETWEEN THE PLASTIC TRAY AND THE TYVEK LID ON ALL EIGHT DEVICES, FIGURE # 1 THRU FIGURE # 4. THE STERILITY OF ALL EIGHT DEVICES WAS COMPROMISED AS EVIDENCED BY THE DAMAGE TO SEALS; THE TYVEK LIDS LOST ADHESION BETWEEN THE PVC ADHESIVE AND THE PLASTIC TRAY SUCH THAT THE PVC ADHESIVE REMAINED ATTACHED TO THE TYVEK LID AS OPPOSED TO BEING ATTACHED TO THE RIM OF THE PLASTIC TRAY AND TYVEK LIDS WHICH CAUSED A BREACH IN THE STERILITY OF THE DEVICES. THERE IS NO EVIDENCE OF CONTACT WITH A SUBSTANCE THAT MAY HAVE COMPROMISED THE PVC ADHESIVE WHICH SUGGESTS A MANUFACTURING PROCESS C AUSED THE FAILURE. ON ALL OF THE EIGHT PLASTIC TRAYS AND ON THE CORRESPONDING TYVEK LIDS THERE IS A CONSISTENT PATTERN OF LOST ADHESION OF THE PVC ADHESIVE. UNDER BLACK LIGHT EXAMINATION OF THE DEVICES TYVEK LIDS AND PLASTIC TRAYS; THERE WAS NO OBSERVATION OF RESIDUAL FLUID CONTACT SIGNS WITH A LIQUID SUBSTANCE. FOUR DEVICES WERE SENT TO (B)(4) FOR ANALYSIS ON 13-MAR-2016, SEE SEPARATE REPORT. THREE DEVICES WERE SENT TO (B)(4) ON 13-MAR-2016 FOR ANALYSIS. (B)(4) REPORT: OVERVIEW WORK REQUESTED: POSSIBLE CONTAMINATION PREVENTING ADHESION MATERIAL RECEIVED: 3 PEAK PLASMA BLADES IN PACKAGING SAMPLE DISPOSITION:DISCARD AFTER 30 DAYS ANALYSIS RESULTS THE NON-BONDED AREA OF ALL THREE SAMPLES WAS CAREFULLY STUDIED AND THE MATING SURFACES EXAMINED UNDER AN OPTICAL MICROSCOPE. NO HINT OF ANY OILY FILM OR OTHER CONTAMINANT WHICH WOULD INTERFERE WITH ADHESION WAS DETECTABLE. THE ADHESIVE IN THESE AREAS LOOKED IN PRISTINE CONDITION, AS THOUGH NO HEAT/PRESSURE HAD BEEN APPLIED. THESE OBSERVATIONS, AS WELL AS THE FACT THAT THE NON-BONDED AREAS WERE IN THE SAME APPROXIMATE LOCATION ON ALL THREE PACKAGES, SUGGESTS A MECHANICAL OR HEAT RELATED ISSUE AND NOT FOREIGN CONTAMINATION. MANUFACTURING ANALYSIS ((B)(4)) REPORT: ROOT CAUSE INVESTIGATION: 100% IN-PROCESS INSPECTION AS DOCUMENTED IN LHR AND 100% POST PROCESS VISUAL INSPECTION AS DOCUMENTED IN I-SHEET WAS PERFORMED FOR CONTINUOUS SEAL LINE AND PACKAGE INTEGRITY. 100% PASSED BOTH INSPECTIONS. NO NCMR WAS OBSERVED OR RECORDED FOR POTENTIAL FAILURE MODE OF ¿MORE THAN 1 LID PLACED ON TRAY FOR SEALING¿. COMPLAINT PRODUCT WAS PACKAGED AND SEALED ON NOVEMBER 16, 2015. (B)(4).

    Description of Event or Problem · 1

    PRIOR TO THE START OF AN ENT CASE, THE OR STAFF NOTICED THE DEVICE SEAL (BETWEEN TYVEK LID AND DEVICE TRAY) WAS BROKEN IN THE TOP CORNER, COMPROMISING ITS STERILITY. A SECOND DEVICE FROM THE SAME LOT NUMBER WAS CHECKED AND THE HAD THE SAME ISSUE. A THIRD DEVICE WAS USED FROM A DIFFERENT UNKNOWN LOT NUMBER TO COMPLETE THE CASE. AFTER THE CASE WAS COMPLETE, THE OR STAFF FOUND 6 ADDITIONAL DEVICES FROM THE SAME INITIAL LOT NUMBER, WITH COMPROMISED STERILITY. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225753 PLASMABLADE PS300-002 4PK TNA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS300-002 0210427425

    Patients

    Seq Age Sex Outcome Treatment
    1