BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR REFURBISHED

    MDR report key: 2842329 · Received November 21, 2012

    Report

    Report Number
    1226420-2012-00074
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 23, 2012
    Report Date
    January 31, 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

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4) EVALUATION PROCESS: UNIT RECEIVED IN POOR CONDITION AND FRONT PANEL OVERLAY HAD A SCRATCH THAT RUNS THROUGH COAG DOWN BUTTON. INTERNAL VISUAL INSPECTION REVEALED NOTHING BROKEN OR MOVING IN THE UNIT. THE FIBERGLASS SCREW IN THE UNIT BASE WAS DAMAGED DURING REMOVAL. THE UNIT WOULD NOT RECOGNIZE ATTACHED PROBES AND TROUBLESHOOTING REVEALED A PARTIALLY SEVERED WIRE IN THE MONOPOLAR HARNESS ASSEMBLY. AFTER REPLACEMENT OF THE HARNESS, UNIT RECOGNIZED ALL PROBES ATTACHED. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS; CUT FUNCTION OPERATED CORRECTLY EVERY TIME IT WAS ACTIVATED AND COAG CEASED TRANSMITTING WHEN DEACTIVATED EVERY TIME. NO FUNCTIONAL ANOMALIES WERE DETECTED. ERROR LOG CONTAINS NO ERRORS OR FAULTS. ROOT CAUSE: IT IS UNCLEAR HOW THE REPORTED PROBLEM OCCURRED AS IT COULD NOT BE REPRODUCED IN THE SERVICE DEPARTMENT. THE DAMAGE TO THE MONOPOLAR HARNESS MAY HAVE BEEN INDUCED BY STRESSES IMPARTED ON IT BY THE WAY THE HARNESS WAS ORIENTED WITHIN THE UNIT. (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 CHICKEN DEMO AT DOCTORS OFFICE CUT FUNCTION WOULD NOT WORK AND WHEN COAG ACTIVATED IT WOULD STICK (STAY ACTIVATED) UNTIL THE DEVICE WAS UNPLUGGED. ISSUE REPEATED WHEN SECOND TRIED. NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    DURING A CHICKEN DEMO AT DOCTOR'S OFFICE CUT FUNCTION WOULD NOT WORK AND WHEN COAG ACTIVATED IT WOULD STICK (STAY ACTIVATED) UNTIL THE DEVICE WAS UNPLUGGED. ISSUE REPEATED WHEN SECOND TRIED. NO PATIENT INVOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1