BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS ELECTROSURGICAL UNIT

    MDR report key: 2421525 · Received January 12, 2012

    Report

    Report Number
    3003724334-2012-00006
    Event Type
    Injury
    Date Received
    January 12, 2012
    Date of Event
    November 27, 2011
    Report Date
    November 27, 2011
    Manufacturer
    CELON AG MEDICAL INSTRUMENTS
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. THE DEVICE SERIAL NUMBER IS FROM A RANGE OF DEVICES WHERE COUNTERFEIT CAPACITORS WITH A HIGHER PROBABILITY TO FAIL WERE IDENTIFIED ON THE MOTHERBOARD. DEFECTIVE CAPACITORS ON THE HIGH VOLTAGE POWER SUPPLY CAN CAUSE DEVIATIONS OF THE OUTPUT POWER/SIGNAL AND TISSUE EFFECT. THEREFORE, A CORRELATION BETWEEN THE ADVERSE EVENT AND THE DEFECTIVE CAPACITOR IS POSSIBLE, BUT THERE IS NO EVIDENCE THAT THIS WAS THE CAUSE. THE MANUFACTURER HAS INITIATED A WORLDWIDE RECALL ON AFFECTED DEVICES. OLYMPUS AMERICA, INC. HAS INITIATED A RECALL TO ADDRESS THIS MATTER. OLYMPUS AMERICA, INC. (OAI) WAS MADE AWARE OF THIS REPORT BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) ON (B)(4) 2012, ON AN EVENT WHICH OCCURRED OUTSIDE OF THE UNITED STATES. OAI IS FILING THIS REPORT AT THE REQUEST OF THE OEM. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    A LOCAL DISTRIBUTOR REPORTED THAT A "CUSTOMER HAS EXPERIENCED BLEEDS THAT LED TO SURGERY, WHILST USING ESG-100. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ELECTROSURGICAL UNIT ELECTROSURGICAL UNIT GEI CELON AG MEDICAL INSTRUMENTS ESG-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R