BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TNA

    MDR report key: 4930435 · Received July 21, 2015

    Report

    Report Number
    1226420-2015-00117
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 23, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). 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: 0006882332 EXPIRATION DATE: 2016-09-26 QUANTITY RETURNED: 1 TESTING PERFORMED: VISUAL INSPECTION: (DEVICE VISUAL INSPECTION MUST BE FILLED OUT FOR EACH DEVICE RETURNED) DEVICE PACKAGING INSPECTION: RECEIVED IN A CARDBOARD BOX WITH STYROFOAM PELLETS TO FILL THE NEGATIVE SPACE DOUBLE BAGGED WITHIN A LARGE CLEAR ZIP LOCK BAG AND THE DEVICE WITH AN ADENOID TIP ATTACHED INSIDE A BIO-HAZARD BAG NO ORIGINAL PACKAGING WAS INCLUDED AND THE LOT NUMBER AND THE DEVICE NAME CANNOT BE CONFIRMED WITH THE INFORMATION LISTED IN THE GCH NOR CAN THE DEVICE SENT BACK BE CONFIRMED AS THE REPORTED COMPLAINT DEVICE. NO ADDITIONAL PAPERWORK WAS INCLUDED DEVICE VISUAL INSPECTION: DEVICE DEFINITELY APPEARS USED WITH DRIED BLOOD SPLATTERED ALL OVER THE DEVICE AND CORD. THE ADENOID TIP ELECTRODE IS DAMAGED; ELECTRODE WIRE DETACHED AT ONE END, MELTED HOUSING AND HEAVILY CLOGGED WITH ESCHAR. THERE IS NO VISUAL SIGNS RELATED TO THE DESCRIPTION BOTH BUTTONS HAVE A TACTILE FEEL FUNCTIONAL INSPECTION: (IF INSPECTION PERFORMED, MUST BE FILLED OUT FOR EACH DEVICE TESTED) FUNCTIONAL TESTING CANNOT BE PERFORMED DUE TO THE DAMAGE ADENOID TIP, HOUSING MELTED, AND ELECTRODE DETACHED AT ONE END. LHR REVIEW: (LOT NUMBER OF RETURNED PRODUCT OR WHAT IS POPULATED AS THE LOT NUMBER IN GCH), ANY DEVIATIONS, FAILURES, SCRAP, ETC. PERTAINING TO COMPLAINT DESCRIPTION) A REVIEW OF THE LHR FOR LOT # 0006882332 REVEALED THERE WERE NO PROBLEMS DURING MANUFACTURING THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT DESCRIPTION. INVESTIGATION CONCLUSION: (COMPLAINT CONFIRMED - COMPLAINT NOT CONFIRMED, SUMMARY OF FINDINGS, LIKELY CAUSE OF FAILURE, IMPACT OF FAILURE TO THE FUNCTIONALITY OF THE DEVICE, RECOMMENDATIONS) COMPLAINT NOT CONFIRMED: THE REPORTED ISSUE CONTAINED IN GCH COULD NOT BE DUPLICATED IN THE LABORATORY ENVIRONMENT. THE ADENOID TIP DAMAGE PREVENTS FUNCTIONAL TESTING DUE TO THE ELECTRODE BEING DETACHED AT ONE END; THEREFORE COMPLAINT COULD NOT BE FULLY INVESTIGATED FOR THE ¿FAILURE TO COAG¿ COMPLAINT. THE COMPLAINT WILL BE TRACKED AND TRENDED WITHIN GCH. ADDITIONALLY IT WAS FOUND THAT THE ADENOID TIP ELECTRODE IS DAMAGE AS EVIDENCED BY THE ELECTRODE DETACHMENT AND THE HOUSING MELTING WHICH PREVENTS ACTIVATION AND FLOW OF RF ENERGY THROUGH THE TIP. THE TIP IS ALSO HEAVILY OCCLUDED WITH ESCHAR WHICH IS CONSISTENT WITH LONG PERIODS OF ACTIVATION AND VERY MINIMAL, IF ANY, CLEANING OF THE TIP WHILE IN USE. IT IS LIKELY THE ADENOID TIP WAS NOT FREQUENTLY CLEANED DURING THE PROCEDURE AS STATED IN THE IFU. THE IFU LISTS APPLICABLE WARNINGS AND PRECAUTIONS FOR USE OF THE PLASMABLADE TNA WHICH SPECIFICALLY APPLY AS LISTED BELOW. PRECAUTIONS: THE PEAK PLASMABLADE SHOULD ONLY BE USED BY QUALIFIED MEDICAL PERSONNEL POSSESSING TRAINING IN THE SURGICAL PROCEDURES TO BE PERFORMED. TAKE CARE WHEN HANDLING THE ELECTRODE TIP TO PREVENT POSSIBLE DAMAGE TO THE TIP AND TO PREVENT USER INJURY. TAKE CARE WHEN CLEANING AROUND THE ADENOID WIRE ELECTRODE, AS EXCESSIVE FORCE MAY CAUSE DAMAGE OR BREAKAGE. USE THE LOWEST POWER SETTING AND THE SHORTEST ACTIVATION TIME POSSIBLE TO ACHIEVE THE DESIRED END EFFECT. UNLESS THE PRODUCT IS BEING USED TO SPOT COAGULATE A VESSEL, IT IS RECOMMENDED TO KEEP THE ELECTRODE TIP IN MOTION WHILE ACTIVATED TO AVOID EXCESSIVE ESCHAR BUILDUP. EXCESSIVE ESCHAR BUILDUP CAN COMPROMISE DEVICE PERFORMANCE, INCLUDING REDUCED OR CLOGGED SUCTION. DO NOT USE SHARP OR ABRASIVE INSTRUMENTS OR MATERIALS TO CLEAN ESCHAR BUILDUP ON THE ELECTRODE TIP AS THIS MAY DAMAGE THE TIP. WHEN NOT IN USE, THE DEVICE SHOULD BE PLACED IN A SECURE STERILE LOCATION TO PREVENT ACCIDENTAL DAMAGE TO THE TIP. PRIOR TO INITIAL USE, ENSURE THAT ALL PACKAGE INSERTS, INCLUDING WARNINGS, CAUTIONS, INSTRUCTIONS FOR USE, AS WELL AS THE PULSAR GENERATOR OPERATOR¿S MANUAL, ARE READ AND UNDERSTOOD. WARNINGS: PROPER SUCTION CONNECTION IS IMPORTANT TO PREVENT A BUILDUP OF FLAMMABLE OR OXIDIZING GASES AT THE SURGICAL SITE. DURING USE, MONITOR THE DEVICE FOR INADEQUATE SUCTION PERFORMANCE, WHICH MIGHT BE APPARENT BY EXCESSIVE / VISIBLE SMOKE OR BURNT ODOR. USE THE CLEANING BRUSH PROVIDED TO REMOVE EXCESS ESCHAR BUILD UP AND MAINTAIN A CLEAR CHANNEL FOR SUCTION. DO NOT CONTACT METAL OBJECTS AND INSTRUMENTS WITH THE PEAK PLASMABLADE WHILE POWER IS BEING APPLIED AS UNINTENDED TISSUE DAMAGE AND ELECTRODE TIP DAMAGE COULD OCCUR. REFERENCED DOCUMENTS: (LIST DOCUMENT NUMBER, TITLE, AND REVISION FOR ALL DOCUMENTS UTILIZED TO PERFORM COMPLAINT INVESTIGATION) 42-10-1020 REV. E ¿ WORK INSTRUCTIONS FOR COMPLAINT INVESTIGATIONS ¿ DISPOSABLE DEVICES 31-10-1370 REV. F ¿ PRODUCT SPECIFICATION AND QUALITY PLAN ¿ TNA PRODUCT FAMILY LBL-00125 REV. C ¿ PEAK PLASMABLADE¿ TNA ¿ IFU 61-10-0017 REV. I ¿ DEVICE BUTTON TACTILE TEST PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    DURING ANALYSIS OF A PLASMABLADE TNA DEVICE THAT WAS RETURNED DUE TO A FAILURE TO ACTIVATE, IT WAS IDENTIFIED THAT THE HOUSING OF THE DEVICE TIP MELTED AND THE WIRE DETACHED ON ONE SIDE. NO PATIENT IMPACT OR INJURY. PATIENT INFORMATION UNABLE TO BE OBTAINED,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473579 PLASMABLADE TNA ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS300-002 0006882332

    Patients

    Seq Age Sex Outcome Treatment
    1