BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS ELECTROSURGICAL UNIT

    MDR report key: 2421500 · Received January 12, 2012

    Report

    Report Number
    3003724334-2012-00004
    Event Type
    Injury
    Date Received
    January 12, 2012
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    CELON AG MEDICAL INSTRUMENTS
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE OF THIS REPORT WAS RETURNED TO OLYMPUS KEYMED FOR EVAL. THE EVAL FOUND THAT THE DEVICE OPERATED APPROPRIATELY. A PERIODIC SAFETY CHECK WAS PERFORMED ON (B)(6), 2011, AND PASSED ALL TESTS. THE CAUSE OF THE REPORTED EVENT IS UNK AND USER HANDLING CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OF THE EVENT. THE ESG-100 INSTRUCTION MANUAL STATES, "USER-RELATED ERROR PREVENTION: WARNING: IMPROPER USE. THE SAFETY AND EFFECTIVENESS OF ELECTROSURGICAL INTERVENTIONS DEPENDS NOT ONLY ON THE DESIGN OF THE EQUIPMENT USED, BUT ALSO TO A MAJOR EXTENT ON FACTORS WHICH ARE UNDER THE CONTROL OF THE USER. IT IS THEREFORE EXTREMELY IMPORTANT TO READ, UNDERSTAND AND FOLLOW THE INSTRUCTIONS SUPPLIED WITH THE ELECTROSURGICAL UNIT AND THE ACCESSORIES IN ORDER TO ENSURE SAFETY AND EFFECTIVENESS." OLYMPUS AMERICA, INC. (OAI) WAS MADE AWARE OF THIS REPORT BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) ON (B)(6) 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

    THE USER FACILITY REPORTED THAT THE DEVICE REPORTEDLY CHANGED ITS SETTING DURING USE RESULTING IN THE PT EXPERIENCING A PERFORATION. THE USERS CLAIMED THAT THE GENERATOR CHANGED FROM THE PULSECUT MODE TO CUT 2 MODE WITHOUT ANY MANUAL INTERVENTION AND THE PT JUMPED WITH PAIN. THE USERS ALSO REPORTED NERVE AND MUSCLE STIMULATION WAS OBSERVED, AND PERFORATION AT AN UNIDENTIFIED LOCATION. THE STATUS OF THE PT IS NOT KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R