BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 834359 · Received March 30, 2007

    Report

    Report Number
    1219930-2007-00179
    Event Type
    Injury
    Date Received
    March 30, 2007
    Date of Event
    February 27, 2007
    Report Date
    March 13, 2007
    Manufacturer
    NORTH HAVEN - ISS
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: SLEEVE GASTRECTOMY. PT SEX: UNK. REPORTEDLY, THE STAPLER WAS APPLIED ON GASTRIC ANTRUM; HOWEVER, THE STAPLES DID NOT CLOSE PROPERLY AND A LOSS OF BILE OCCURRED. THE SURGEON THEN ATTEMPTED TO APPLY A SECOND AND THIRD DLU ALONG THE GREATER CURVATURE OF STOMACH, BUT THE DEVICE ONLY CUT THE TISSUE AND THERE WAS IMPROPER STAPLE APPLICATION. THE SURGEON THEN ATTEMPTED TO APPLY A LARGER STAPLE SIZE AND WAS ABLE TO COMPLETE THE STAPLING. HOWEVER, IT WAS NECESSARY TO CHANGE TO AN OPEN PROCEDURE, BECAUSE THE STOMACH WAS TOO MUCH REDUCED AND THEY NEED TO CREATE A GASTRIC BY-PASS VIA A HAND MADE ANASTOMOSIS AND SUTURES FOR WHICH THE SURGERY TIME HAD TO BE EXTENDED. THE REPORT INDICATES THAT: THE PROBLEM OF BILE LOSS WAS SOLVED, ANTIBIOTICS WERE ADMINISTERED TO THE PT, THE PT'S HEALTH CONDITION IS UNDER CONTROL, BUT THE HOSPITALIZATION TIME HAS BEEN EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE SURGICAL STAPLER GAG NORTH HAVEN - ISS * N6L320

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R ENDO GIA ROTICULATOR 60-3.5 DLU LOT#: N6L89M| PRODUCT ID #: 030458