BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS ELECTROSURGICAL UNIT

    MDR report key: 2421524 · Received January 12, 2012

    Report

    Report Number
    3003724334-2012-00005
    Event Type
    Injury
    Date Received
    January 12, 2012
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    CELON AG MEDICAL INSTRUMENTS
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE OF THIS REPORT WAS RETURNED TO THE MANUFACTURER FOR EVAL. THE EVAL FOUND THAT THE DEVICE OPERATED APPROPRIATELY. THE CAUSE OF THE REPORTED EVENTS IS UNK, HOWEVER USER HANDLING CANNOT BE EXCLUDED AS A CONTRIBUTORY EVENT. THE ESG-100 INSTRUCTION MANUAL STATES, "USER-RELATED FOR 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

    OLYMPUS WAS INFORMED THAT THE USER EXPERIENCED THREE PT PERFORATIONS IN THE FIRST FIVE USES OF THE SUBJECT DEVICE. ONE PERFORATION WAS SAID TO HAVE OCCURRED IN AN UNSPECIFIED AREA OF THE PT'S COLON. THERE WAS NO INFO PROVIDED REGARDING THE LOCATION OF ANY OF THE OTHER OCCURRENCES, NOR THE TYPE OF PROCEDURES BEING PERFORMED. THE INFO WAS PROVIDED REGARDING THE STATUS OF THE PATIENT (S) FOLLOWING THE ALLEGED EVENTS.

    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