BEUDAMED
    FDA Adverse Event Injury Summary report: N

    33MM HEMORRHOID STAPLER 3.5MM STAPLES

    MDR report key: 2980917 · Received February 19, 2013

    Report

    Report Number
    1219930-2013-00109
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GDW
    PMA / PMN Number
    K083781
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HEMORRHOID. ACCORDING TO THE REPORTER: 10 CLAMPS WERE NOT FORMED CORRECTLY, PART OF THE SUTURE HAD TO BE STAPLED AGAIN. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500 CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71339 33MM HEMORRHOID STAPLER 3.5MM STAPLES DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SUR N2J0126MX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other