BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR II

    MDR report key: 4154652 · Received October 9, 2014

    Report

    Report Number
    1226420-2014-00094
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 10, 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
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #208952363 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 REPORTED. UNIT DELIVERED CORRECT LEVELS OF RF ENERGY TO RATED LOADS IN ALL MODES AND ACROSS ALL POWER LEVELS. ROOT CAUSE: REPORT OF HIGHER THAN RATED CUT OUTPUT POWER FOR CUT LEVELS 4 AND 5 COULD NOT BE CONFIRMED IN THE SERVICE DEPARTMENT. THE UNIT DELIVERED PRESCRIBED POWER (WITHIN 20% TOLERANCE) TO RATED LOADS IN ALL MODES ACROSS ALL POWER LEVELS. THE SCRATCHES ON THE ENCLOSURE PAINT DOWN TO THE EXPOSED METAL ARE DUE TO ROUGH HANDLING IN THE FIELD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. RESULTS: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. CONCLUSION: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. PRODUCT EVENT: (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A ROUTINE PREVENTATIVE MAINTENANCE CHECK, THE BIOMED DEPARTMENT AT THE HOSPITAL REPORTED THAT THE GENERATOR WAS FOUND TO HAVE HIGH OUTPUT ON CUT 4 AND CUT 5. ALL OTHER SETTINGS WERE WITHIN SPECIFICATION. NO PATIENT IMPACT.

    Description of Event or Problem · 1

    DURING A ROUTINE PREVENTATIVE MAINTENANCE CHECK, THE BIOMED DEPARTMENT AT THE HOSPITAL REPORTED THAT THE GENERATOR WAS FOUND TO HAVE HIGH OUTPUT ON CUT 4 AND CUT 5. ALL OTHER SETTINGS WERE WITHIN SPECIFICATION. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634100 GENERATOR PULSAR II GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY (SALIENT) PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1