BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 3515083 · Received December 4, 2013

    Report

    Report Number
    2647580-2013-00635
    Event Type
    Injury
    Date Received
    December 4, 2013
    Report Date
    November 19, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC ASSISTED TOTAL GASTRECTOMY. ACCORDING TO THE REPORTER IN A LITERATURE REVIEW: AN ARTICLE TITLED "STENOSIS AFTER USE OF THE DOUBLE STAPLING TECHNIQUE FOR RECONSTRUCTION AFTER LAPAROSCOPY ASSISTED TOTAL GASTRECTOMY", IN THE JOURNAL OF SURGICAL ENDOSCOPY 2013 27: 3683.3689, STATES A RETROSPECTIVE ANALYSIS WAS CONDUCTED FROM 2008 TO 2011 ON 262 PTS WITH GASTRIC CANCER WHO UNDERWENT TOTAL GASTRECTOMY AND RECONSTRUCTION WITH A ROUX-EN Y ANASTOMOSIS, AND 52 PTS WHO UNDERWENT LATG WITH DST. POSTOPERATIVE COMPLICATIONS INCLUDED FOUR ANASTOMOTIC LEAKS. THE MORTALITY RATE WAS ZERO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628063 UNKNOWN EEA NONE GAG COVIDIEN, FORMERLY USSC PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other