BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONMED LAPAROSCOPIC ABC PROBE

    MDR report key: 2071830 · Received April 21, 2011

    Report

    Report Number
    1720159-2011-00015
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 13, 2011
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED ELECTROSURGERY RECEIVED THE ORIGINAL DEVICE IN QUESTION ALONG WITH THE SIX LOT SAMPLES. IT WAS CONFIRMED THAT THE ORIGINAL DEVICE WAS BURNT. ALSO, WE DID RECEIVE CONFIRMATION THAT THE FACILITY'S BIOMEDICAL ENGINEER PULLED BACK THE INSULATION TO EXAMINE THE DEVICE FURTHER. ADDITIONALLY, ONE OF THE LOT SAMPLES WAS SUBJECTED TO AN ESU (ELECTROSURGICAL UNIT) INTERFACE TEST, WHICH SIMULATES ACTUAL USE, AND PASSED.

    Description of Event or Problem · 1

    THE 5MM LAP PROBE FIRED CORRECTLY ON THE OVARIAN CYSTS. ABOUT HALF WAY THROUGH THE PROCEDURE THE PROBE STOPPED FIRING WHEN ACTIVATED. THE SETTINGS WERE RE-CHECKED AND THE LINE WAS PURGED. THE PROBE WOULD NOT FIRE. IT WAS REMOVED FROM THE TROCAR AND THEY DISCOVERED MELTED INSULATION EXPOSING THE ELECTRODE AND PATIENT BURNS ON UTERUS. THE PATIENT WAS NOT RE-ADMITTED DUE TO ADVERSE EVENTS. THE BURNS WERE 'RIGHT AT THE JUNCTION OF THE UTERUS AND THE UTERO-OVARIAN PEDICLE,' BUT THEY WERE SUPERFICIAL WITH NO BLEEDING. ALSO, THERE WAS NO INTERVENTION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED LAPAROSCOPIC ABC PROBE ARGON BEAM COAGULATOR PROBE, CODE: GEI GEI CONMED ELECTROSURGERY 1009013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other