BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLDVAC SLIM,PUSH BUTTON,10FT

    MDR report key: 8670628 · Received June 5, 2019

    Report

    Report Number
    1320894-2019-00190
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 5, 2019
    Manufacturer
    BUFFALO FILTER
    Product Code
    GEI
    PMA / PMN Number
    K103375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER, BUFFALO FILTER LLC, IS RESPONSIBLE FOR PERFORMING THE EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT. ON BEHALF OF THE CUSTOMER, THE (B)(4) REPRESENTATIVE REPORTED AN ISSUE WITH THE GOLDVAC SLIM, PUSH BUTTON, 10FT, ITEM # 60-7610-001, SERIAL # (B)(4) THAT OCCURRED (B)(6) 2019. IT WAS REPORTED THAT "RESIDENT WAS OPERATING INSIDE THE ABDOMINAL CAVITY WHEN THE ELECTRODE CAUGHT ON FIRE - THERE WAS ACTUALLY A FLAME". IT IS INDICATED THAT THERE WAS NO IMPACT OR INJURY TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A COVIDIEN PENCIL WITH NO REPORTED DELAY. ADDITIONAL INFORMATION OBTAINED INDICATES THAT TOWARDS THE BEGINNING OF A "WHIPPLE PROCEDURE" THE RESIDENT WAS DISSECTING INSIDE THE ABDOMINAL CAVITY WHEN THE PENCIL CAUGHT FIRE. IT WAS NOTED THAT IT DIDN'T LOOK LIKE THERE WAS ANY BUILD UP ON THE BLADE WHEN THE FLAME APPEARED. THE FLAME WAS PRESENT ONLY FOR A BRIEF TIME AND DISCONNECTED. THE SURGEON REVERTED TO A COVIDIEN PENCIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465973 GOLDVAC SLIM,PUSH BUTTON,10FT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BUFFALO FILTER 030519

    Patients

    Seq Age Sex Outcome Treatment
    1