BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BP-ROBOTIC

    MDR report key: 2820186 · Received November 2, 2012

    Report

    Report Number
    3005350457-2012-00001
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 4, 2012
    Report Date
    November 2, 2012
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K070157
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION INVOLVED A SINGLE USE BP-ROBOTIC LASER-FIBER. THE MALFUNCTION RESULTED FROM A FAILURE OF GLUE JOINT WHICH ALLOWED A PORTION OF THE SINGLE USE DEVICE TO SHIFT INSIDE AN OMNIGUIDE REUSABLE SURGICAL INSTRUMENT, CAT# FLEXGUIDE ULTRA, IN A MANNER NOT CONSISTENT WITH NORMAL USAGE. THE MALFUNCTION WAS EASILY IDENTIFIED BY THE SURGEON. DURING THE CASE, THE SINGLE USE DEVICE WAS REPLACED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT AN ADVERSE OUTCOME. OMNIGUIDE (THE MANUFACTURER) HAS DETERMINED THERE IS A POTENTIAL FOR A SERIOUS ADVERSE EVENT. THE SERIOUS ADVERSE EVENT BASED ON THE IDENTIFIED MALFUNCTION WOULD BE A PIECE OF THE DEVICE SEPARATING AND FALLING INTO THE PATIENT, RESULTING IN ACCIDENTAL IMPLANTATION OF THE DEVICE. THIS SERIOUS ADVERSE EVENT CAN HAPPEN ONLY IF THE PHYSICIAN FAILS TO IDENTIFY AND REMOVE THE PIECE PRIOR TO COMPLETING THE SURGERY. (B)(4). THE MANUFACTURER HAS ISOLATED THIS FAILURE TO THE LOT NUMBERS. THE MANUFACTURER IS REQUESTING AND EFFECTING A VOLUNTARY RECALL OF THE AFFECTED DEVICES.

    Description of Event or Problem · 1

    REPORTED BY (B)(6), FOR CASE AT (B)(6) HOSPITAL, FOR MYOMECTOMY PERFORMED BY DR (B)(6) OF THE INSTITUTE (B)(6). (B)(4). REPORTED COMPLAINT TEXT: "BP-ROBOTIC FIBER PASSED THROUGH THE TIP OF THIS FLEXGUIDE - ULTRA DURING A CASE. SENDING BACK FOR EXAMINATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BP-ROBOTIC GEX, 21CFR878.4810 GEX OMNIGUIDE, INC. LA120910AO-P1

    Patients

    Seq Age Sex Outcome Treatment
    1