BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL TIP

    MDR report key: 3723837 · Received March 18, 2014

    Report

    Report Number
    1213643-2014-00071
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    October 11, 2013
    Report Date
    February 18, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    GEI
    PMA / PMN Number
    K010444
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED PER MAUDE EVENT REPORT MW 5033552 AND PER THE USER FACILITY: (B)(6) 2013: DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WITH THE BOVIE SET AT 30, A PIECE OF THE SHEATH MATERIAL ON THE ELECTROSURGICAL TIP BURNED OFF AND FELL INTO THE ABDOMEN OF THE PATIENT. THE SURGEON NOTICED THIS WHEN IT HAPPENED AND REMOVED THE ENTIRE PIECE IMMEDIATELY. NO HARM WAS REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159661 ELECTROSURGICAL TIP GEI DAVOL INC., SUB. C.R. BARD, INC. NA DAXCAT25

    Patients

    Seq Age Sex Outcome Treatment
    1