BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR II

    MDR report key: 4176324 · Received October 16, 2014

    Report

    Report Number
    1226420-2014-00100
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    September 17, 2014
    Report Date
    January 9, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #700727913 EVALUATION PROCESS: PERFORMED VISUAL INSPECTION ON UNIT PER TCL-514-900008. -UNIT HAS A DENT ON THE REAR OF ENCLOSURE. -UNIT HAS SCRATCHES IN THE ENCLOSURE PAINT. -UNIT HAS NUMBERS WRITTEN ON THE SIDE OF THE ENCLOSURE WITH PERMANENT, BLACK MARKER. PERFORMED BASELINE FUNCTIONED TESTING PER TCL-514-900008. -NO ISSUES FOUND. UNIT DELIVERED CORRECT LEVELS OF RF ENERGY IN ALL MODES ACROSS ALL ENERGY LEVELS. SPECIFICALLY (AMONGST OTHER SETTINGS) THE UNIT WAS CONFIGURED TO DELIVER 30W OF SPRAY COAGULATION ENERGY TO A 500-OHM NON-INDUCTIVE RESISTOR [THIS CORRESPONDS TO COAGULATION SETTING ¿6¿ ON A 3.0S HANDPIECE.] THE UNIT WAS MEASURED TO DELIVER 30.26W OF OUTPUT POWER, LESS THAN 1% HIGHER THAN THE TARGET OUTPUT POWER AND WELL WITHIN ALLOWABLE TOLERANCE OF +/- 20%. ROOT CAUSE: COULD NOT CONFIRM COMPLAINT OF HIGH OUTPUT POWER FOR COAG 6 (3.0S HANDPIECE.) THE UNIT DELIVERS OUTPUT POWER WITHIN 20% OF THE TARGET VALUES IN ALL MODES, ACROSS ALL POWER LEVELS, IN THE SERVICE DEPARTMENT. DENT AND SCRATCHES ON THE ENCLOSURE ARE DUE TO ROUGH HANDLING IN THE FIELD. NUMBERS (PERMANENT BLACK MARKER) WERE WRITTEN ON THE ENCLOSURE WHILE IN THE FIELD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD/RESULTS/CONCLUSION: PRODUCT RETURNED AND ANALYSIS RESULTS PENDING.

    Description of Event or Problem · 1

    DURING A ROUTINE PREVENTATIVE MAINTENANCE CHECK, THE FACILITY'S BIOMED DEPARTMENT REPORTED THAT THE UNIT WAS FOUND TO HAVE HIGH OUTPUT ON COAG 6. ALL OTHER SETTINGS WERE FINE. NO PATIENT IMPACT.

    Description of Event or Problem · 1

    DURING A ROUTINE PREVENTATIVE MAINTENANCE CHECK, THE FACILITY'S BIOMED DEPARTMENT REPORTED THAT THE UNIT WAS FOUND TO HAVE HIGH OUTPUT ON COAG 6. ALL OTHER SETTINGS WERE FINE. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659515 GENERATOR PULSAR II GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY (SALIENT) PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1