BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBISHED PULSAR GENERATOR

    MDR report key: 4764475 · Received May 12, 2015

    Report

    Report Number
    1226420-2015-00078
    Event Type
    Malfunction
    Date Received
    May 12, 2015
    Date of Event
    April 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K073057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION PROCESS: PERFORMED VISUAL INSPECTION (B)(4): -NO ISSUES NOTED. PERFORMED BASELINE PERFORMANCE TESTING (B)(4): -WHEN USING HANDPIECE BUTTONS, CUT WILL NOT ACTIVATE BUT COAG WILL. HOWEVER, COAG WILL NOT SHUT OFF WHEN BUTTON RELEASED. FOOTSWITCH OPERATION OPERATES NORMALLY. TROUBLESHOOTING FOUND CRACKED SOLDER JOINT AT RF AMPLIFIER CAPACITOR C154. REFLOWING JOINT CORRECTED MALFUNCTION. ROOT CAUSE: -BROKEN SOLDER JOINT AT RF AMPLIFIER CAPACITOR C154 PREVENTED ELIMINATION OF AC RIPPLE ON COAG HAND SWITCH LOGIC LEVEL SIGNAL. (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT (B)(4). EVALUATION PROCESS: PERFORMED VISUAL INSPECTION IAW (B)(4): NO ISSUES NOTED. PERFORMED BASELINE PERFORMANCE TESTING IAW (B)(4): WHEN USING HANDPIECE BUTTONS, CUT WILL NOT ACTIVATE BUT COAG WILL. HOWEVER, COAG WILL NOT SHUT OFF WHEN BUTTON RELEASED. FOOTSWITCH OPERATION OPERATES NORMALLY. TROUBLESHOOTING FOUND CRACKED SOLDER JOINT AT RF AMPLIFIER CAPACITOR C154. REFLOWING JOINT CORRECTED MALFUNCTION. ROOT CAUSE: BROKEN SOLDER JOINT AT RF AMPLIFIER CAPACITOR C154 PREVENTED ELIMINATION OF AC RIPPLE ON COAG HAND SWITCH LOGIC LEVEL SIGNAL. SYSTEM APPROACH: THE REPORTED EVENT IS INCLUSIVE OF THE GENERATOR ONLY AND NOT ASSOCIATED WITH ANY DEVICES. THE REPORT INVOLVES A COMPONENT FAILURE REGARDLESS OF UTILIZATION OF ANY ASSOCIATED DEVICE, THEREFORE THE DEVICE IS RULED OUT AS A CONTRIBUTING FACTOR TO THIS INCIDENT. (B)(4).

    Description of Event or Problem · 1

    WHEN COAG MODE WAS ACTIVATED ON THE PULSAR SYSTEM RF ENERGY WAS DELIVERED AS EXPECTED BUT, WHEN RELEASING THE COAG ACTIVATION BUTTON RF ENERGY WAS STILL BEING DELIVERED AND THE PULSAR SYSTEM DISPLAY SHOWED THAT THE SYSTEM WAS ACTIVATED. NO PATIENT IMPACT OR INJURY.

    Description of Event or Problem · 1

    WHEN COAG MODE WAS ACTIVATED ON THE PULSAR SYSTEM RF ENERGY WAS DELIVERED AS EXPECTED BUT, WHEN RELEASING THE COAG ACTIVATION BUTTON RF ENERGY WAS STILL BEING DELIVERED AND THE PULSAR SYSTEM DISPLAY SHOWED THAT THE SYSTEM WAS ACTIVATED. NO PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309111 REFURBISHED PULSAR GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS100-100RF

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR