BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 2896045 · Received December 27, 2012

    Report

    Report Number
    1219930-2012-01026
    Event Type
    Injury
    Date Received
    December 27, 2012
    Report Date
    November 30, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SLEEVE GASTRECTOMY. AS REPORTED IN LITERATURE: ONE HUNDRED EIGHTEEN PATIENTS WITH MBI } 30 UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY. FROM (B)(6) 2006 TO (B)(6) 2009, ONE HUNDRED EIGHTEEN PATIENTS WITH BMI } 30 UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY. THE STUDY NOTES THAT THE LAPAROSCOPIC AUTOSUTURE STAPLERS FROM BOTH COVIDIEN AND ETHICON WERE USED IN THE STUDY. POSTOPERATIVE LEAKAGES WERE IDENTIFIED IN 4 PATIENTS (3.39%). ALL FOUR PATIENTS HAD LEAKAGE FROM THE EG JUNCTION. ONE OF THE LEAKS RESOLVED WITH CONSERVATIVE TREATMENT OF NOTHING BY MOUTH AND INTRAVENOUS NUTRITION. TWO PATIENTS REQUIRED REOPERATION FOR FISTULA EXCLUSION AND PARTIAL LUNG RESECTION. ONE PATIENT REQUIRED REOPERATION FOR DRAINAGE OF ABSCESSED FEEDING JEJUNOSTOMY. ALL FOUR PATIENTS REQUIRED PROLONGED HOSPITAL STAY. REINFORCEMENT MATERIAL WAS NOT USED IN THIS PATIENT GROUP. PATIENT WITH AN EG JUNCTION LEAK, REOPERATION FOR FISTULA EXCLUSION AND PARTIAL LUNG RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ENDO GIA SULU NONE GDW COVIDIEN, FORMERLY US SUR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R