BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILA 52 ANASTOMOTIC TITANIUM DLU

    MDR report key: 2250020 · Received September 9, 2011

    Report

    Report Number
    2647580-2011-00604
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 19, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    KNH
    PMA / PMN Number
    K885047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ROUX-EN-Y. ACCORDING TO THE REPORTER: WHEN THE DUODENUM WAS CUT, THE FIRING WAS ABLE TO BE DONE PROPERLY. WHEN THE ANASTOMOSIS WAS DONE AFTER THE ESOPHAGOJEJUNOSTOMY, THE STUMP OF THE JEJUNUM WAS CUT BY THIS DEVICE. THE FIRING KNOB COULD NOT BE FULLY EXTENDED. THE KNOB WAS RETURNED AND RELEASED FROM THE TISSUE. ADDITIONAL RESECTION OF TISSUE WAS NEEDED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. OOZING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILA 52 ANASTOMOTIC TITANIUM DLU DISPOSABLE LOADING UNIT KNH USSC PUERTO RICO P1C0392

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability