BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PS100-102 PULSAR II

    MDR report key: 4329137 · Received December 15, 2014

    Report

    Report Number
    1226420-2014-00124
    Event Type
    Malfunction
    Date Received
    December 15, 2014
    Date of Event
    November 18, 2014
    Report Date
    April 10, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT # (B)(4). EVALUATION PROCESS: PERFORMED VISUAL INSPECTION ON UNIT PER TCL-514-900008. -UNIT HAS SCRATCHES DOWN TO THE EXPOSED METAL. PERFORMED BASELINE FUNCTIONAL TESTING PER TCL-514-900008. NO ISSUES FOUND. UNIT DELIVERED CORRECT LEVELS OF RF ENERGY IN ALL MODES. CUT LEVEL 6 WITH A 3.0S HANDPIECE COMMANDS THE PULSAR II TO DELIVER 20W OF MEDIUM CUT TO RATED LOAD (40OHM.) THE REPORT THAT THE OUTPUT MEASURED 25W MEANS THAT THE OUTPUT POWER WAS 25% HIGHER THAN RATED POWER(THIS EXCEEDS THE MAXIMUM ALLOWABLE DIFFERENCE OF 20% AND IS THE REASON OR THE COMPLAINT.) THE INCOMING INSPECTION FOR THE PULSAR II TESTED THE UNIT ACROSS A RANGE OF POWER ISSUES WHEN DELIVERING ANY MODE, INCLUDING MEDIUM CUT, TO RATED LOAD IN THE SERVICE DEPARTMENT. THE COMPLAINT COULD NOT BE CONFIRMED. ROOT CAUSE: SERVICE DEPARTMENT COULD NOT REPLICATE REPORTED DISCREPANCY: UNIT DELIVERED CORRECT LEVELS OF RF ENERGY IN ALL MODES, INCLUDING MEDIUM CUT (THE MODE IDENTIFIED IN THE COMPLAINT.) SCRATCHES ON THE ENCLOSURE PAINT ARE DUE TO ROUGH HANDLING IN THE FIELD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT (B)(4). EVALUATION (METHOD): GENERATOR RETURNED AND PENDING ANALYSIS RESULTS. EVALUATION (RESULT): GENERATOR RETURNED AND PENDING ANALYSIS RESULTS. EVALUATION (CONCLUSION): GENERATOR RETURNED AND PENDING ANALYSIS RESULTS. (B)(4).

    Description of Event or Problem · 1

    DURING ROUTINE BIOMED TESTING WITH A FLUKE ANALYZER AND PLASMABLADE 3.0S, THE OUTPUT ON CUT SETTING 6 IS HIGHER THAN THE EXPECTED OUTPUT VALUE. PLASMABLADE WAS USED ON ANOTHER UNIT TO TEST AND OUTPUT VALUES MET SPECIFIED GUIDELINES. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    DURING ROUTINE BIOMED TESTING WITH A FLUKE ANALYZER AND PLASMABLADE 3.0S, THE OUTPUT ON CUT SETTING 6 IS HIGHER THAN THE EXPECTED OUTPUT VALUE. PLASMABLADE WAS USED ON ANOTHER UNIT TO TEST AND OUTPUT VALUES MET SPECIFIED GUIDELINES. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820285 GENERATOR PS100-102 PULSAR II GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1