BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURVED EEA 31 STAPLER

    MDR report key: 1252389 · Received December 4, 2008

    Report

    Report Number
    2647580-2008-00681
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 25, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 12/04/2008.

    Description of Event or Problem · 1

    THIS PRODUCT IS NOT SOLD/DISTRIBUTED IN THE UNITED STATES. PROCEDURE: SIGMOID AND RECTAL JUNCTION RADICAL CANCER MASTECTOMY. ACCORDING TO THE REPORTER: AFTER APPLYING THE STAPLER, THE SURGEON NOTICED THAT NOT ALL TISSUE LAYERS WERE INCORPORATED IN THE ANASTOMOSIS. THERE WAS 1CM LEAKAGE IN THE ANASTOMOSIS WHERE NO STAPLES WERE SEEN. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO STOMA WAS NECESSARY AND NO BLEEDING OCCURRED, BUT SURGERY TIME WAS EXTENDED BY MORE THAN THIRTY MINUTES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVED EEA 31 STAPLER DISPOSABLE SURGICAL STAPLER GDW PONCE - USS P7D0017R

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention