BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL GENERATOR

    MDR report key: 3780665 · Received April 18, 2014

    Report

    Report Number
    2951238-2014-00156
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 1, 2014
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    GEI
    PMA / PMN Number
    K73207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVAL. THE BIPOLAR, MONOPOLAR CUT AND COAG FUNCTIONS ARE RESPONDING ACCORDINGLY TO THE ACTIVATION OF THE CUT AND COAG SWITCHES OF THE TEST FOOTSWITCH. THE DEVICE WAS TESTED AND PASSED ALL FUNCTION TESTS. THE EXACT CAUSE OF THE PT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THE DEVICE WAS WORKING APPROPRIATELY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A COLONOSCOPY PROCEDURE WHILE THE PHYSICIAN WAS REMOVING A POLYP AND COAGULATING, THE ELECTROSURGICAL GENERATOR JUMPED AND SPIKED, CAUSING A PERFORATION IN THE PT'S COLON. A SURGICAL PROCEDURE WAS THEN PERFORMED TO REPAIR THE PERFORATION. THE PT WAS HOSPITALIZED FOR A COUPLE OF DAYS AND THEN TRANSFERRED TO A (B)(6) HOSPITAL BY PT DECISION. THE PT WAS IN STABLE CONDITION WHEN HE WAS DISCHARGED. AFTER THE PROCEDURE, THE GENERATOR WAS POWERED ON AND THE FOOTPEDAL WAS TESTED, FOR CUT AND COAG FUNCTIONS. THE DEVICE WORKED FINE WHEN TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238862 ELECTROSURGICAL GENERATOR ELECTROSURGICAL UNIT GEI GYRUS ACMI INC. ESG-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R