BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ENDO GIA SULU

    MDR report key: 2618979 · Received June 12, 2012

    Report

    Report Number
    1219930-2012-00491
    Event Type
    Injury
    Date Received
    June 12, 2012
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON: (B)(4) 2012.

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC GASTRIC SLEEVE RESECTION SURGERY FOR MORBID OBESITY. ACCORDING TO THE REPORTER: ON OR ABOUT (B)(6) 2011, THE PT UNDERWENT LAPAROSCOPIC GASTRIC SLEEVE RESECTION SURGERY FOR MORBID OBESITY AT (B)(6) HOSPITAL; (B)(6). AS PART OF THE SURGICAL PROCEDURE PERFORMED, THE SURGEON TRANSECTED THE STOMACH USING A STAPLING DEVICE AND STAPLES DESIGNED, MANUFACTURED, AND SOLD BY (B)(4). ON (B)(6) 2011, THE PT HAD A SUDDEN ONSET OF EPIGASTRIC PAIN ASSOCIATED WITH FEVER AND CHILLS. AN UPPER GI DEMONSTRATED A LEAK FROM THE PREVIOUS STAPLE LINE AND THIS FINDING WAS CONFIRMED BY CT SCAN. THE PT WAS TAKEN INTO THE OPERATING ROOM WHERE THE SURGEON PERFORMED A DIAGNOSTIC LAPAROSCOPY. AS A RESULT OF THE LEAKAGE FROM HER STAPLE LINE, THE PT DEVELOPED MASSIVE MULTIPLE INFECTIONS AND OTHER COMPLICATIONS REQUIRING EXTENDED HOSPITALIZATIONS AND SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK ENDO GIA SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R