BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 3942008 · Received July 17, 2014

    Report

    Report Number
    1226420-2014-00051
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT (B)(4). METHOD, RESULTS, CONCLUSION: GENERATOR NOT RETURNED THEREFORE ANALYSIS UNABLE TO BE PERFORMED. (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 TONSIL AND ADENOIDECTOMY CASE THE PLASMABLADE TNA DEVICE (ADENOID TIP) SPARKED. THE GENERATOR SETTINGS AT THE TIME OF THE SPARK WERE COAG 8, CUT 1, BUT THE OXYGEN SETTING WAS UNKNOWN. NO PATIENT IMPACT (PATIENT DETAILS REFUSED TO BE GIVEN BY USER FACILITY). *DUE TO THE FACT THAT THE GENERATOR COULD NOT BE RULED OUT AS THE CAUSE OR A CONTRIBUTING FACTOR TO THE REPORTED INCIDENT IT IS DEEMED REPORTABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418651 PULSAR GENERATOR GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC MAE UNK PEAK GEN

    Patients

    Seq Age Sex Outcome Treatment
    1