BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 25MM STAPLER WITH 3.5MM STAPLES

    MDR report key: 1233947 · Received November 14, 2008

    Report

    Report Number
    1219930-2008-00828
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 24, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: THIS OPERATION STARTED AS A LAPAROSCOPIC GASTRECTOMY AND WAS CONVERTED TO OPEN PROCEDURE (PLANNED CONVERSION). A LINEAR STAPLER WAS APPLIED TO THE BLIND END OF JEJUNUM. ESOPHAGOJEJUNOSTOMY WAS PERFORMED PROPERLY WITH THE EEA AND THE DR COMPLETED THE PROCEDURE WITHOUT CONDUCTING LEAK TEST. THE LEFT DRAIN WAS REMOVED FROM THE PT ONE DAY POST-OPERATIVELY. THREE DAYS POST-OPERATIVELY, UPON TAKING AN X-RAY, THE PT FELT A SNAPPING FEELING IN HIS BODY; HE REPORTED PAIN WITHIN THE LEFT SIDE OF HIS ABDOMEN AND PRODUCED A FEVER. A CT AND MRI WERE PERFORMED AND CONFIRMED A LEAKAGE. A METALLIC HALATION WAS OBSERVED AT THE ANASTOMOTIC SITE. THE SURGEON HAS NOT BEEN ABLE TO DETERMINE IF STAPLE FORMATION WAS THE CAUSE. AS OF CURRENT, A REOPERATION HAS NOT BEEN PERFORMED AND NEITHER IS IT PLANNED. THE PT IS CURRENTLY IN THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 25MM STAPLER WITH 3.5MM STAPLES DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R