BEUDAMED
    FDA Adverse Event Other Summary report: N

    BP-LE

    MDR report key: 2974789 · Received January 15, 2013

    Report

    Report Number
    3005350457-2013-00001
    Event Type
    Other
    Date Received
    January 15, 2013
    Date of Event
    November 16, 2012
    Report Date
    February 14, 2013
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K071057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: DEVICE WAS DISCARDED BY USER FACILITY AFTER USE, AND WAS NOT RETURNED TO OMNIGUIDE INC., THE MANUFACTURER, FOR EVALUATION. DEVICE RELATIONSHIP TO INJURY: NO INDICATION OF DEVICE CONTRIBUTION TO THE ADVERSE EVENT HAS BEEN REPORTED TO THE MANUFACTURER BY THE USER FACILITY OR FROM ANY OTHER SOURCE. THIS REPORT IS BEING FILED AS THE DEVICE WAS USED ON THE PATIENT INJURED. PATIENT EXPERIENCED SUBCUTANEOUS EMPHYSEMA POSTOPERATIVELY. PHYSICIAN DISCHARGE SUMMARY ASSESSED THE EMPHYSEMA WAS LIKELY DUE TO CO2 GAS (FROM CO2 INSUFFLATION FOR THE LAPAROSCOPIC SURGERY) INFILTRATING THE SUBCUTANEOUS TISSUE FOUND IN THE LAPAROSCOPIC PROCEDURE PERFORMED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY ON (B)(6). THE OMNIGUIDE INC. DEVICE, BP-LE, WAS USED FOR LASER DESTRUCTION OF LESIONS. THE PATIENT WAS DISCHARGED TO HOME IN STABLE CONDITION. DURING THE POSTOPERATIVE HOURS THE PATIENT WAS EXPERIENCING PAIN IN HER ABDOMEN AND CHEST AND ADMITTED HERSELF TO THE LOCAL ER. PATIENT WAS DIAGNOSED WITH SUBCUTANEOUS EMPHYSEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23618 BP-LE GEX, 21CFR878.4810 GEX OMNIGUIDE, INC. BP-LE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization