BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS ELECTROSURGICAL UNIT

    MDR report key: 2421505 · Received January 12, 2012

    Report

    Report Number
    3003724334-2012-00008
    Event Type
    Injury
    Date Received
    January 12, 2012
    Date of Event
    August 2, 2011
    Report Date
    August 3, 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

    OLYMPUS WAS INFORMED THAT THE SUBJECT DEVICE WAS INSPECTED THE FOLLOWING DAY AND FOUND TO HAVE NO PROBLEM. THE SETTINGS WERE SET FOR FORCEDCOAG 2, LEVEL 35. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED TO THE MANUFACTURER FOR EVAL. THE CAUSE OF THE REPORTED EVENT IS UNK. 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

    DURING AN UNIDENTIFIED PROCEDURE, THE PT WAS SAID TO HAVE REPORTED PAIN. AFTER THE PROCEDURE WAS COMPLETED, THE PT REPORTED TENSION AND PAIN IN THE ABDOMEN. AN X-RAY WAS PERFORMED AND DETECTED AN AIR LEAK. THE PT UNDERWENT EMERGENCY SURGERY TO CORRECT THE PERFORATION.

    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