BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PS100-100 PULSAR

    MDR report key: 2867781 · Received December 11, 2012

    Report

    Report Number
    1226420-2012-00089
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 9, 2012
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC,
    Product Code
    MUL
    PMA / PMN Number
    K073057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION PROCESS: UNIT RECEIVED IN FAIR CONDITION AND INTERNAL VISUAL INSPECTION FOUND NOTHING MOVING OR BROKEN IN THE UNIT. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS AND POWER WAS CHECKED IN ALL MODES AND POWER LEVELS AND ALL WERE WITHIN ACCEPTABLE LIMITS. UNIT WAS ALSO TESTED WITH PLASMABLADE INTO AN ANALOG SUBSTANCES AND EVENT AT THE HIGHEST POWER LEVELS NO HEATING OF THE PROBE WAS NOTED. (B)(4).

    Description of Event or Problem · 1

    TIP OF PLASMABLADE CAUGHT FIRE. DOCTOR PERFORMED TWO T<(>&<)>A CASES AFTER THE INCIDENT WITH THE PEAK TNA PLASMABLADE WITHOUT INCIDENT.

    Description of Event or Problem · 1

    TIP OF PLASMABLADE CAUGHT FIRE. DOCTOR PERFORMED TWO SUBSEQUENT TNA CASES AFTER THE INITIAL INCIDENT WITH THE PEAK TNA PLASMABLADE WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERATOR PS100-100 PULSAR GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC, PS100-100

    Patients

    Seq Age Sex Outcome Treatment
    1