BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II GENERATOR

    MDR report key: 2880560 · Received December 19, 2012

    Report

    Report Number
    1226420-2012-00106
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 3, 2012
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT# (B)(4). EVALUATION PROCESS: UNIT RECEIVED IN GOOD CONDITION AND INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. TO ENSURE THAT THE CUT AND COAG ENERGY DELIVERY WAS NOT WEAK STEP 5.6 AND 5.12 OF THE FINAL TEST (TP-0050) WERE PERFORMED AND THE POWER MEASUREMENTS WERE WITHIN TOLERANCE. TO ESTABLISH THAT THE UNIT DELIVERED ENERGY CORRECTLY IN CUT AND COAG MODES THE ACTIVE BURN-IN PORTION OF TEST PROCEDURE TP-0048 WAS PERFORMED AND THE UNIT PASSED WITH NO ISSUES. ERROR LOG: 4 E3 (PATIENT RETURN ELECTRODE HAS POOR CONNECTION), 5 E5 (MONOPOLAR HANDPIECE HAS REACHED END OF LIFE) AND BOTH ARE CONSIDERED NORMAL USE ERRORS. ROOT CAUSE: UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS IN BOTH CUT AND COAG MODES IN THE DEVICE DEPARTMENT. UNIT DOES NOT EXHIBIT LOW POWER OUTPUT. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD, RESULTS AND CONCLUSION: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. PRODUCT EVENT: (B)(6).

    Description of Event or Problem · 1

    DURING BILATERAL BREAST REDUCTION CASE THE PLASMABLADE LOST COAGULATION FUNCTIONALITY. GENERATOR WAS SWAPPED OUT AND DEVICES FROM SAME LOT USED WITHOUT FURTHER INCIDENT. IT WAS NOTED THAT HOSPITAL WAS UTILIZING THE SAME POWER CORD FOR USE WITH MULTIPLE MEDICAL DEVICES AND NOT THE POWER CORD EXCLUSIVE TO THE PULSAR GENERATOR.

    Description of Event or Problem · 1

    DURING BILATERAL BREAST REDUCTION CASE PLASMABLADE DEVICE LOST COAGULATION FUNCTIONALITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1