BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP

    MDR report key: 3070741 · Received April 15, 2013

    Report

    Report Number
    3006451981-2013-00110
    Event Type
    Injury
    Date Received
    April 15, 2013
    Report Date
    February 27, 2013
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS...
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: SURGEON STATES THAT DURING A PROCEDURE PERFORMED BETWEEN (B)(6) 2012 AND (B)(6) 2013 ON THE LEFT SIGMOID COLON AND RECTUM FOR COLON CANCER, THE PROCEDURE WENT WELL. THEY CONFIRMED TWO FULL DONUTS AND DID A SUCCESSFUL LEAK TEST. THE PT WENT HOME TWO DAYS LATER. SUBSEQUENTLY, THE PT CAME BACK A WEEK LATER WITH A LEAK. A RE-OPERATION WAS PERFORMED AND THE PT WAS GIVEN A TEMPORARY COLOSTOMY. NO FURTHER INFO REGARDING THE PT IS AVAILABLE AS THE PT WENT TO ANOTHER SURGEON FOR F/U CARE. NO STAPLE LINE REINFORCEMENT MATERIAL WAS USED IN THE PROCEDURE. SURGEON STATED THERE COULD HAVE BEEN A PT/TECHNIQUE/TISSUE/OTHER PROBLEM. THE LOT NUMBER OF THE DEVICE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161856 PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP DISPOSABLE STAPLING DEVICE GDW COVIDIEN MEDICAL PRODUCTS...

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R