BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3212771 · Received July 1, 2013

    Report

    Report Number
    2647580-2013-00365
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 27, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: BOWEL RESECTION. ACCORDING TO THE REPORTER: EMERGENCY LAPAROSCOPIC SURGERY PERFORMED DUE TO INTESTINAL OBSTRUCTION. UPON FIRING, DEVICE DID NOT CUT. NO TISSUE "DOUGHNUTS" WERE MADE PREVENTING THE DEVICE TO BE REMOVED FROM THE PT AS THE TISSUE REMAINED STUCK IN THE DEVICE. IN ORDER TO SOLVE THE PROBLEM THEY HAD TO RECONVERT THE LAPAROSCOPIC SURGERY INTO AN OPEN AND THEN THEY HAD TO CUT PART OF THE REMAINING RECTUM IN ORDER TO EXTRACT THE DEVICE. THERE WAS ABOUT 2 HOURS DELAY DUE TO THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297431 PREMIUM PLUS CEEA* 31 INSTR. W/TILT-TOP* DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO P9J0555J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other