BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6202187

    MDR report key: 6202187 · Received December 23, 2016

    Report

    Report Number
    6202187
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 20, 2016
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SINUS SURGERY AND REPAIR OF CSF LEAK NOTED STENBERGER BIPOLAR AND ENDO PEN TRIAL (NEURO) #700986S HAD THE TIPS BURNED. BOTH INSTRUMENTS WITH BURNED TIPS WERE REMOVED FROM THE FIELD. THE ESU CONSOLE WAS SET AT 45. THE REST OF THE SURGERY THE REGULAR BIPOLAR FORCEPS WERE USED WITH THE SAME ESU CONSOLE (WITH THE SETTINGS OF 30) AND WORKED FINE.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR THE ESU CONSOLE IS: CONMED, MODEL# 60-2450-120, CE