BEUDAMED
    FDA Adverse Event Injury Summary report: N

    33 HEMORRHOID STAPLER 4.8MM STAPLES

    MDR report key: 2782107 · Received October 3, 2012

    Report

    Report Number
    1219930-2012-00810
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 18, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083781
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HEMORRHOIDECTOMY. ACCORDING TO THE REPORTER: SURGEON STATES THAT STAPLES ARE ALL OPENED. THE SURGICAL TIME EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. THE PATIENT EXPERIENCED INCREASED PAIN POST-OPERATIVELY. THE STAPLE FORMATION PROBLEM TREATED BY MANUAL SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 33 HEMORRHOID STAPLER 4.8MM STAPLES DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N2E0164UMX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other