BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SABRE 2400

    MDR report key: 2093535 · Received May 16, 2011

    Report

    Report Number
    2093535
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 16, 2011
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT TAKEN TO OR FOR EXPLORATORY LAPAROSCOPY AFTER ULTRASOUND SHOWED FREE FLUID IN ABDOMEN. CASE CONVERTED TO OPEN VIA OLD INCISION. ABDOMEN CONTAINED LARGE AMOUNT OF BLOOD AND IRRIGATION FLUID. ESU ELECTROSURGICAL UNIT DID NOT APPEAR TO BE MAKING CONTACT, PER SURGEON TURNED UP AS HIGH AS IT WOULD GO. TOWARDS END OF CASE, NOTED BURNS ON SKIN OF RIGHT UPPER ABDOMEN. ESU PENCIL LYING ON DRAPE NEAR AREA OF BURNS. BURNED AREA ON ABDOMEN WAS APPROXIMATELY 8 CM LONG IN TOTAL AND APPROXIMATELY 2 CM WIDE AT WIDEST PART. NO ONE HEARD THE PEN ACTIVATE OTHER THAN WHEN IN USE BY SURGEONS. HOLSTER WAS LOCATED ON DRAPE NEAR GENERAL AREA OF BURNS. UNKNOWN IF PENCIL WAS PLACED IN HOLSTER AND CAME OUT DUE TO TENSION ON CORD OR IF PENCIL WAS NOT PLACED IN HOLSTER. BURNED AREA DEBRIDED BY SURGEON AND DRESSED WITH SILVADENE. PER WOUND CARE NURSE, 3RD DEGREE BURN HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABRE 2400 ELECTROSURGICAL GENERATOR GEI CONMED CORPORATION SABRE 2400 *
    2 BUTTON SWITCH PENCIL ESU PENCIL GEI MEGADYNE MEDICAL PRODUCTS, INC 60-5600-002 *
    3 E-Z CLEAN PENCIL TIP GEI MEGADYNE MEDICAL PRODUCTS, INC * *
    4 SUREFIT DUAL DISPERSIVE ELECTRODE GEI CONMED CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R