BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 1631621 · Received March 12, 2010

    Report

    Report Number
    1219930-2010-00210
    Event Type
    Injury
    Date Received
    March 12, 2010
    Report Date
    March 2, 2010
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE GROUP
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4).

    Description of Event or Problem · 1

    ACCORDING TO AN ARTICLE PUBLISHED ON OBES SURG 19:821-826 (2009) TITLED "NONSURGICAL TREATMENT OF STAPLE LINE LEAKS AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY" A SERIES OF 2000 LAP SLEEVE GASTRECTOMIES WERE PERFORMED AT (B) (6) BETWEEN (B) (6) 2002 AND (B) (6) 2008. STAPLE LINE LEAKS OCCURRED IN SIX PTS (MEAN BMI 52.5; (B) (6)). LEAK PRESENTATION WAS EARLY IN THREE CASES (FIRST, SECOND AND THIRD POSTOPERATIVE DAY), LATE IN THE REMAINING THREE CASES (11TH, 22ND, AND 30TH DAY POST OPERATIVE). THE MOST COMMON LEAK LOCATION WAS AT THE ESOPHAGOGASTRIC JUNCTION (FIVE CASES). MORTALITY WAS NIHIL. NONOPERATIVE MANAGEMENT (TOTAL PARENTERAL NUTRITION, PROTON PUMP INHIBITOR, AND ANTIBIOTICS) WAS ADOPTED IN ALL CASES. PERCUTANEOUS ABDOMINAL DRAINAGE WAS PLACED IN FIVE PTS. IN ONE CASE, A SMALL FISTULA WAS SUCCESSFULLY TREATED BY ENDOSCOPIC INJECTION OF FIBRIN GLUE. SELF EXPANDABLE COVERED STENT WAS USED IN THREE CASES, COMPLETE HEALING OF LEAKS WAS OBTAINED IN ALL PTS (MEAN HEALING TIME 71 DAYS). THE GASTRIC POUCH IS CREATED BY USING A LINEAR STAPLER (ENDO GIA, (B) (4)) WITH TWO SEQUENTIAL 4.8/60-MM GREEN LOAD FIRINGS FOR THE ANTRUM, FOLLOWED BY TWO OR THREE SEQUENTIAL 3.5/60-MM BLUE CARTRIDGES FOR THE REMAINING GASTRIC CORPUS AND FUNDUS. THE STAPLER IS APPLIED ALONGSIDE OF 48-FR CALIBRATING BOUGIE TIGHTLY POSITIONED AGAINST THE LESSER CURVE, TO OBTAIN AN 80-120-ML GASTRIC POUCH. IN THE FIRST 100 CASES, THE SUTURE LINE REINFORCEMENT WAS USED ONLY IN FOUR PTS. A METHYLENE BLUE DYE TEST IS ROUTINELY PERFORMED THROUGH NASOGASTRIC TUBE. STAPLE LINE LEAKS OCCURRED IN SIX PTS (3%). IN THESE SIX CASES, NO INTRAOPERATIVE COMPLICATIONS HAD OCCURRED AND THE METHYLENE BLUE TEST WAS NEGATIVE FOR STAPLE LINE LEAKAGE. IN FOUR CASES, NO REINFORCEMENT OF THE SUTURE LINE HAS BEEN PERFORMED, WHILE, IN TWO CASES, AN OVERSEWING REINFORCEMENT HAS BEEN CARRIED OUT. IN ONE CASE AN ASYMPTOMATIC SMALL FISTULA WAS SUCCESSFULLY TREATED BY ENDOSCOPIC INJECTION OF FIBRIN GLUE WITHOUT ANY ADDITIONAL THERAPEUTIC MEASURE. IN THREE CASES, THE FISTULA PERSISTED FOR MORE THAN 4 WEEKS. A SELF EXPANDING STENT WAS PLACED UNDER FLUOROSCOPIC AND ENDOSCOPIC CONTROL. MEAN HOSPITAL STAY WAS 41 DAYS. THE MOST COMMON LOCATION OF THE LEAK WAS JUST BELOW THE ESOPHAGOGASTRIC JUNCTION (FIVE OF SIX CASES) POSSIBLY RELATED TO THE HIGH INTRAGASTRIC PRESSURE WITH IMPAIRED PERISTALTIC ACTIVITY AND ISCHEMIA. IN ONE PT, THE FISTULA LOCATION WAS AT THE ANTRUM AT THE JUNCTION OF THE SEQUENTIAL STAPLER FIRINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ENDO GIA SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention