BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 7663853 · Received July 5, 2018

    Report

    Report Number
    2647580-2018-03326
    Event Type
    Injury
    Date Received
    July 5, 2018
    Date of Event
    June 1, 2018
    Report Date
    July 5, 2018
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REFERENCES 1. HESS DS, HESS DW. BILIOPANCREATIC DIVERSION WITH A DUODENAL SWITCH. OBES SURG. 1998;8:267¿282. 2. GLUCK B, MOVITZ B, JANSMA S, ET AL. LAPAROSCOPIC SLEEVE GASTRECTOMY IS A SAFE AND EFFECTIVE BARIATRIC PROCEDURE FOR THE LOWER BMI (35.0-43.0 KG/M2) POPULATION. OBES SURG. 2011;21:1168¿1171. 3. BOHDJALIAN A, LANGER FB, SHAKERI-LEIDENMÜHLER S, ET AL. SLEEVE GASTRECTOMY AS SOLE AND DEFINITIVE BARIATRIC PROCEDURE: 5-YEAR RESULTS FOR WEIGHT LOSS AND GHRELIN. OBES SURG. 2010;20:535¿540. 4. LALOR PF, TUCKER ON, SZOMSTEIN S, ET AL. COMPLICATIONS AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY. SURG OBES RELAT DIS. 2008; 4:33¿38. 5. ABD ELLATIFM, ABBAS A, EL NAKEEB A, ET AL. MANAGEMENT OPTIONS FOR TWISTED GASTRIC TUBE AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY. OBES SURG. 2017;27:2404¿2409. 6. GAGNER M, DEITEL M, KALBERER TL, ET AL. THE SECOND INTERNATIONAL CONSENSUS SUMMIT FOR SLEEVE GASTRECTOMY, MARCH 19-21, 2009. SURG OBES REL DIS. 2009;5:476¿485. 7. BRETHAUER S, HAMMEL J, SCHAUER P. SYSTEMATIC REVIEW OF SLEEVE GASTRECTOMY AS STAGING AND PRIMARY BARIATRIC PROCEDURE. SURG OBES REL DIS. 2009;5:469¿475. 8. CHEN B, KIRIAKOPOULOS A, TSAKAYANNIS D, ET AL. REINFORCEMENT DOES NOT NECESSARILY REDUCE THE RATE OF STAPLE LINE LEAKS AFTER SLEEVE GASTRECTOMY. A REVIEW OF THE LITERATURE AND CLINICAL EXPERIENCES. OBES SURG. 2009;19:166¿172. 9. AGGARWAL S, SHARMA AP, RAMASWAMY N. OUTCOME OF LAPAROSCOPIC SLEEVE GASTRECTOMY WITH AND WITHOUT STAPLE LINE OVERSEWING IN MORBIDLY OBESE PATIENTS: A RANDOMIZED STUDY. J LAPAROENDOSC ADV SURG TECH A. 2013;23:895¿899. 10. BAKER RS, FOOTE J, KEMMETER P, ET AL. THE SCIENCE OF STAPLING AND LEAKS. OBES SURG. 2004;14:1290¿1298. 11. D¿UGO S, GENTILESCHI P, BENAVOLI D, ET AL. COMPARATIVE USE OF DIFFERENT TECHNIQUES FOR LEAK AND BLEEDING PREVENTION DURING LAPAROSCOPIC SLEEVE GASTRECTOMY: A MULTICENTER STUDY. SURG OBES RELAT DIS. 2014;10:450¿454. 12. SHIKORA SA, KIM JJ, TARNOFF ME. COMPARISON OF PERMANENT AND NONPERMANENT STAPLE LINE BUTTRESSING MATERIALS FOR LINEAR GASTRIC STAPLE LINES DURING LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS. SURG OBES RELAT DIS. 2008;4:729¿734. 13. DOWNEY DM, HARRE JG, DOLAN JP. INCREASED BURST PRESSURE IN GASTROINTESTINAL STAPLE-LINES USING REINFORCEMENT WITH A BIOPROSTHETIC MATERIAL. OBES SURG. 2005;15:1379¿1383. 14. SIMON TE, SCOTT JA, BROCKMEYER JR, ET AL. COMPARISON OF STAPLE-LINE LEAKAGE AND HEMORRHAGE IN PATIENTS UNDERGOING LAPAROSCOPIC SLEEVE GASTRECTOMY WITH OR WITHOUT SEAMGUARD. AM SURG. 2011;77:1665¿1668. 15. CHOI YY, BAE J, HUR KY, ET AL. REINFORCING THE STAPLE LINE DURING LAPAROSCOPIC SLEEVE GASTRECTOMY: DOES IT HAVE ADVANTAGES? A METAANALYSIS. OBES SURG. 2012;22:1206¿1213. 16. AURORA AR, KHAITAN L, SABER AA. SLEEVE GASTRECTOMY AND THE RISK OF LEAK: A SYSTEMATIC ANALYSIS OF 4,888 PATIENTS. SURG ENDOSC. 2012;26:1509¿1515. 17. GAGNER M, BUCHWALD JN. COMPARISON OF LAPAROSCOPIC SLEEVE GASTRECTOMY LEAK RATES IN FOUR STAPLE-LINE REINFORCEMENT OPTIONS: A SYSTEMATIC REVIEW. SURG OBES RELATDIS. 2014;10: 713¿723. 18. NIMERI A, MAASHER A, SALIM E, ET AL. THE USE OF INTRAOPERATIVE ENDOSCOPY MAY DECREASE POSTOPERATIVE STENOSIS IN LAPAROSCOPIC SLEEVE GASTRECTOMY. OBES SURG. 2016;26:1398¿1401. 19. WANG Z, DAI X, XIE H, ET AL. THE EFFICACY OF STAPLE LINE REINFORCEMENT DURING LAPAROSCOPIC SLEEVE GASTRECTOMY: A META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS. INT J SURG. 2016; 25:145¿152. 20. BURGOS AM, CSENDES A, BRAGHETTO I. GASTRIC STENOSIS AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY IN MORBIDLY OBESE PATIENTS. OBES SURG. 2013;23:1481¿1486. 21. SUBHAS G, GUPTA A, SABIR M, ET AL. GASTRIC REMNANT TWIST IN THE IMMEDIATE POSTOPERATIVE PERIOD FOLLOWING LAPAROSCOPIC SLEEVE GASTRECTOMY. WORLD J GASTROINTEST SURG. 2015;7:345¿348. 22. AFANEH C, COSTA R, POMP A, ET AL. A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL ASSESSING THE EFFICACY OF OMENTOPEXY DURING LAPAROSCOPIC SLEEVE GASTRECTOMY IN REDUCING POSTOPERATIVE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, POST OPERATIVELY, FOLLOWING A LAPAROSCOPIC SLEEVE GASTRECTOMY, ONE PATIENT COMPLAINED OF ABDOMINAL PAIN AND HAD A HIGH FEVER. CT SCAN WITH CONTRAST DETECTED AN ANASTOMOTIC LEAK. THE PATIENT WAS CONSERVATIVELY TREATED WITH A STENT AND NASOJEJUNAL CATHETER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507028 ENDO GIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EGIA SU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention