BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS ELECTROSURGICAL UNIT

    MDR report key: 2427124 · Received January 13, 2012

    Report

    Report Number
    3003724334-2012-00011
    Event Type
    Injury
    Date Received
    January 13, 2012
    Date of Event
    January 24, 2011
    Report Date
    February 7, 2011
    Manufacturer
    CELON AG MEDICAL INSTRUMENTS
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE REPORTED EVENT IS UNK, HOWEVER 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 MFR (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 CUSTOMER CARRIED OUT ENDOSCOPIC SUBMUCOSAL RESECTION (EMR) WITH THE SUBJECT DEVICE ESG-100 AND A SD-210U-15 SNARE. THE SETTING WAS FORCED COAGULATION 2 AND OUTPUT WAS 20W. AFTER EMR, THE PT REPORTEDLY FELT PAIN. THE USERS MONITORED THE PT CONDITION AND IT WAS CONSIDERED THAT A PERFORATION MAY HAVE OCCURRED. 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