BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE PURSTRING 65 INSTRUMENT

    MDR report key: 3800208 · Received April 28, 2014

    Report

    Report Number
    2647580-2014-00319
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    January 6, 2014
    Report Date
    April 25, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GDW
    PMA / PMN Number
    K901107
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOIDECTOMY. ACCORDING TO THE REPORTER: THE HANDLE OF THE DEVICE BROKE. A SMALL PLASTIC PIECE OF THE DEVICE BROKE OF AND FELL INTO THE ABDOMINAL CAVITY. IT WAS SUBSEQUENTLY RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253940 DISPOSABLE PURSTRING 65 INSTRUMENT DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P3K0518X

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention