BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS ELECTROSURGICAL UNIT

    MDR report key: 2426183 · Received January 13, 2012

    Report

    Report Number
    3003724334-2012-00010
    Event Type
    Injury
    Date Received
    January 13, 2012
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    CELON AG MEDICAL INSTRUMENTS
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. THE CAUSE OF THE REPORTED EVENT IS UNKNOWN. 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 FILLING 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

    THE USER FACILITY REPORTED THAT THEY ALWAYS USED THE SUBJECT DEVICE WITH SETTINGS OF 15W FORCED COAGULATION. HOWEVER, THE USERS ATTEMPTED TO EXCISE A LARGE POLYP THAT WAS DIFFICULT TO CUT, AND INSTEAD ATTEMPTED TO USE SETTINGS OF 25W PULSE CUT SLOW. THE PATIENT REPORTEDLY EXPERIENCED UNCONTROLLED BLEEDING. THERE WAS NO FURTHER INFORMATION PROVIDED REGARDING THE STATUS OF THE PATIENT.

    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