BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 1893641 · Received November 3, 2010

    Report

    Report Number
    2647580-2010-00881
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 4, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOWER ANTERIOR RESECTION. ACCORDING TO THE RPTR: AFTER THE DEVICE WAS USED, A LEAK WAS FOUND AT THE ANASTOMOSIS. DURING THE CASE, UNANTICIPATED TISSUE LOSS OCCURRED. ANOTHER DEVICE WAS USED TO PERFORM A SECOND TRANSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER SURGICAL STAPLER GDW USSC PUERTO RICO P0G0612H

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability