BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II GENERATOR

    MDR report key: 2870290 · Received December 12, 2012

    Report

    Report Number
    1226420-2012-00098
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 13, 2012
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION PROCESS: UNIT RECEIVED IN GOOD CONDITION AND INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. DISTORTED WAVEFORMS EVIDENT IN BOTH CUT AND COAG MODES. FOUND R7 (5.1OHM) READING OPEN CIRCUIT AND R8 (5.1OHM) READING 1.2KOHMS ON RF BOARD. AFTER RESOLDERING R7 AND R8 ON THE RF BOARD THE UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. RF AMPLIFIER PCBA IS BUILT ON OBSOLETE PCB AND DC POWER SUPPLY PCBA IS BUILT ON OBSOLETE PCB AND DUE TO THE COST OF UPGRADING THIS UNIT THE UNIT WILL BE SCRAPPED. ROOT CAUSE: COMPONENTS R7 AND R8 ON THE RF AMP BOARD HAD CRACKED/COLD SOLDER JOINTS PREVENTING THE OUTPUT TRANSFORMER FROM BEING DRIVEN PROPERLY. (B)(4).

    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).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    GENERATOR WORKING SPORADICALLY, FAILURE TO CUT OR COAG, NO POWER TO DEVICE. ELECTROCAUTERY UTILIZED TO COMPLETE CASE.

    Description of Event or Problem · 1

    GENERATOR WORKING SPORADICALLY, FAILURE TO CUT OR COAG, NO POWER TO DEVICE. ELECTROCAUTERY UTILIZED TO COMPLETE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1