BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA* 31 INSTR. S/TILT-TOP*

    MDR report key: 3212762 · Received July 1, 2013

    Report

    Report Number
    2647580-2013-00367
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 27, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K001895
    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: LAR. ACCORDING TO THE REPORTER: AFTER FIRING, A PART OF TISSUE WAS NOT CUT AND THE DEVICE COULD NOT BE REMOVED. THE SURGEON GOT THE RECTUM OUT OF THE ANUS AND CUT AND TREATED THE UNCUT PART WITH ANOTHER DEVICE (COOPER SCISSORS, ETC), WHICH RESULTED IN THE UNANTICIPATED TISSUE LOSS. AFTER THAT, LEAK TEST WAS PERFORMED AND LEAK FROM A PART OF THE STAPLE LINE WAS OBSERVED. THEREFORE, THE PART WAS SUTURED LAPAROSCOPICALLY, AND COVERING STOMA WAS CREATED. THE COVERING STOMA WAS NOT PLANNED ORIGINALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297313 PREMIUM PLUS CEEA* 31 INSTR. S/TILT-TOP* DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other