BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 4.0

    MDR report key: 4401579 · Received January 9, 2015

    Report

    Report Number
    1226420-2015-00006
    Event Type
    Malfunction
    Date Received
    January 9, 2015
    Date of Event
    September 26, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4). INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) LHR REVIEW COMPLAINT DEVICE DETAILS: DEVICE NAME: PLASMABLADE¿ 4.0, PRODUCT NUMBER: PS200-040, LOT NUMBER: FL50762396, EXPIRATION DATE: 2016-09-01, QUANTITY RETURNED: (B)(4). TESTING PERFORMED: DEVICE PACKAGING INSPECTION: PLASMABLADE¿ 4.0 RECEIVED INSIDE A CARDBOARD BOX WITH NO PAPER TO FILL THE NEGATIVE SPACE AND NOT WITHIN BIOHAZARD BAGS. PLASTIC TRAY AND TYVEK® LID RETURNED AND THE DEVICE INFORMATION MATCHES THE INFORMATION THAT IS LISTED IN THE PRODUCT EVENT PAGE WITHIN (B)(4). HANDWRITTEN NOTE ¿DID NOT WORK ¿ TRIED 2 MACHINES¿ INCLUDED DEVICE VISUAL INSPECTION: DEVICE APPEARS CLEAN AND UNUSED. ALL COMPONENTS APPEAR IN PLACE AND INTACT. THE BLADE COATING HAS CHIPPING AT THE ELECTRODE TIP, FIGURE # 1. THE COAG BUTTON HAS DEFINITIVE TACTILE FEEL; HOWEVER, THE CUT BUTTON DOES NOT. FUNCTIONAL INSPECTION: THE PLASMABLADE¿ 4.0 WAS CONNECTED TO THE COMPLAINT LAB PULSAR® II GENERATOR AND THE EXPECTED E5 ERROR CODE, END OF LIFE, WAS NOT DISPLAYED INDICATING THAT THE DEVICE HAD NEVER BEEN SUCCESSFULLY BEEN ACTIVATED BY A GENERATOR PRIOR TO COMPLAINT INVESTIGATION. UPON DEPRESSION OF THE COAG BUTTON THE GENERATOR ILLUMINATED THE COAG FUNCTION ON THE DISPLAY SCREEN AND AN AUDIBLE HIGH PITCHED NOISE WAS HEARD COMING FROM THE GENERATOR WHICH INDICATES THE DEVICE HAS BEEN ACTIVATED. UPON DEPRESSION OF THE CUT BUTTON THE GENERATOR DID NOT ILLUMINATE THE CUT FUNCTION ON THE DISPLAY SCREEN AND NO HIGH PITCHED NOISE WAS HEARD COMING FROM THE GENERATOR WHICH INDICATES THAT THE DEVICE FAILED TO ACTIVATE. THE DEVICE WAS TESTED FOR CONTINUITY PER 31-10-1368 REV. D: ELECTRICAL CONTINUITY: <(><<)>(><(><<)><(><<)>)> 5 OHMS RESISTANCE PER CIRCUIT, ELECTRODE TO APPROPRIATE PLUG END. THE BUTTON CIRCUITS MUST HAVE CONTINUITY WITH A RESISTANCE OF LESS THAN 10 OHMS WHEN DEPRESSED WITH 350 GRAMS (F); FINGER PRESSURE WAS APPLIED TO THE BUTTONS WHILE MEASURING CONTINUITY, WITH UNACCEPTABLE RESULTS FOR THE CUT BUTTON. PIN # 1 - CUT POWER = 1.4 OHMS PIN # 4 - CUT BUTTON = OL PIN # 3 - COAG POWER = 1.6 OHMS PIN # 2 - COAG BUTTON = 1.9 OHMS THE INTERACTION BETWEEN THE BUTTON AND THE DOME SWITCH WAS NO WORKING. OPENED UP THE DEVICE AND THERE IS NORMAL TACTILE FEEL ON THE DOME SWITCH OF THE PCB BOARD AS THIS IS LIKELY DUE TO VARIATION IN THE MANUFACTURING PROCESS OR VARIATION IN THE COMPONENTS. RESIDUE IS PRESENT ON THE FRONT AND BACK OF THE PLASTIC COVERING ON THE PCB BOARD, FIGURES # 2 THRU FIGURE # 5. THE WIRES WERE CONNECTED AND SOLDERED IN THEIR PROPER LOCATION ON THE PCB BOARD, FIGURE # 6. THE NOSE OF THE DEVICE WAS DIFFICULT TO ROTATE AT MULTIPLE POSITIONS. THE METAL ROTATOR SHAFT HAS RESIDUE ALONG THE SHAFT, FIGURE # 7(NEW METAL ROTATOR SHAFT) AND FIGURE # 8 (COMPLAINT DEVICE). THERE WAS RESIDUE ON THE PLASTIC COVERING ON THE PCB BOARD AND INSIDE THE DEVICE ON THE METAL ROTATOR SHAFT. THE DEVICE WILL BE SENT TO (B)(4) FOR ANALYSIS OF THE RESIDUE OBSERVED AND FOR THE BLADE COATING CHIPPING ON THE TIP. INVESTIGATION CONCLUSION: THE COMPLAINT IS CONFIRMED FOR THE ¿FAILURE TO ACTIVATE¿ ISSUE THAT WAS REPORTED IN THE COMPLAINT DESCRIPTION. THE DEVICE WAS TESTED FOR CONTINUITY AND FAILED TO MEET THE PRODUCT SPECIFICATIONS FOR THE CUT FUNCTION AS INDICATED BY AN OL (OPEN LOOP) READING. THE INTERACTION BETWEEN THE BUTTON AND THE DOME SWITCH WAS NO WORKING. THE DEVICE WAS OPENED UP AND THERE WAS NORMAL TACTILE FEEL ON THE DOME SWITCH OF THE PCB BOARD AS THIS IS LIKELY DUE TO VARIATION IN THE MANUFACTURING PROCESS OR VARIATION IN THE COMPONENTS. THE NOSE OF THE DEVICE WAS DIFFICULT TO ROTATE AT MULTIPLE POSITIONS. THE METAL ROTATOR SHAFT HAS RESIDUE ALONG THE SHAFT. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE COMPLAINT WILL BE TRACKED AND TRENDED IN THE DEVICE HAS BEEN SENT TO MEDTRONIC (B)(4) FOR ROOT CAUSE ANALYSIS FOR THE BLADE FAILURE ANALYSIS; ¿IN ORDER TO INVESTIGATE THE RESIDUE ON PLASTIC COVERING THE PCB BOARD AND METAL ROTATOR SHAFT, AN UNUSED, RETAINED DEVICE WAS OPENED TO COMPARE WITH THE CUSTOMER RETURNED DEVICE. RETAINED SAMPLES SHOW SIMILAR SURFACE CONDITION OF THE PLASTIC COVER AND ROTATOR SHAFT.¿ ¿ALL STEPS OF THE MANUFACTURING PROCESS WERE VERIFIED AND FOUND IN COMPLIANCE WITH THE APPLICABLE PROCEDURES / WORK INSTRUCTIONS / INSPECTIONS AND THERE IS NO EVIDENCE THAT THIS COMPLAINT IS RELATED TO A MANUFACTURING PROCESS DEFECT. NO ABNORMALITIES OR NON-CONFORMANCES WERE FOUND IN THE DEVICE HISTORY RECORD OF THE AFFECTED LOTS RELATED TO THE REPORTED COMPLAINT. THE PLASMABLADE¿ DEVICE WAS MANUFACTURED ACCORDING TO ESTABLISHED MANUFACTURING PROCESSES.¿ (B)(4).

    Description of Event or Problem · 1

    DURING FUNCTIONAL ANALYSIS OF A PLASMABLADE 4.0 DEVICE THAT WAS RETURNED DUE TO A FAILURE TO ACTIVATE, IT WAS IDENTIFIED THAT THE DEVICE COATING HAD PEELED/FLAKED/CHIPPED OFF. NO PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23777 PLASMABLADE 4.0 ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC PS200-040 FL50762396

    Patients

    Seq Age Sex Outcome Treatment
    1