BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX 60 ARTICULATING

    MDR report key: 8218891 · Received January 4, 2019

    Report

    Report Number
    3005075853-2019-15507
    Event Type
    Injury
    Date Received
    January 4, 2019
    Report Date
    December 10, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001706
    PMA / PMN Number
    K081146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. THE ARTICLE WAS REVIEWED BY COMPANY MEDICAL SAFETY OFFICER. SINCE THE ARTICLE STATES THAT A REOPERATION OCCURRED 4 MONTHS AFTER THE INITIAL SLEEVE GASTRECTOMY PROCEDURE DUE TO ABSOLUTE NONCOMPLIANCE OF THE PATIENT, IT HAS BEEN CONCLUDED THAT THE PATIENT DEATH IS NOT RELATED TO THE USE OF STAPLING DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH JOURNAL ARTICLE TITLE: LAPAROSCOPIC SLEEVE GASTRECTOMY AS FIRST STAGE OR DEFINITIVE INTENT IN 300 CONSECUTIVE CASES AUTHOR(S): N. BASSO ¿ G. CASELLA ¿ M. RIZZELLO ¿ F. ABBATINI ¿ E. SORICELLI ¿ G. ALESSANDRI ¿ C. MAGLIO ¿ A. FANTINI CITATION: SURG ENDOSC (2011) 25:444¿449; DOI 10.1007/S00464-010-1187-7. THIS STUDY WAS DESIGNED TO EVALUATE THE RESULTS OF LAPAROSCOPIC SLEEVE GASTRECTOMY (SG) ON COMPLICATIONS, BODY MASS INDEX (BMI), AND COMORBIDITIES RESOLUTION IN 300 CONSECUTIVE OBESE PATIENTS AND TO ANALYZE THE LESSON LEARNED FROM THIS EXPERIENCE. FROM OCT2002 TO NOV2009, 300 PATIENTS UNDERWENT SG FOR FIRST STAGE OF BILIOPANCREATOC DIVERSION WITH DUODENAL SWITCH (N=100; N=63 FEMALE AND N=27 MALE; MEAN BMI OF 54.4 KG/M2 [RANGED 39-81 KG/M2]; MEAN AGE OF 43.6 YEARS [RANGED 21-58 YEARS]) AND FOR DEFINITIVE BARIATRIC PROCEDURE (N=200; N=138 FEMALE AND N=62 MALE; MEAN BMI OF 45.5 KG/M2 [RANGED 31-70.5 KG/M2]; MEAN AGE OF 43.1 YEARS [16-67 YEARS]). IN THE PROCEDURE, HARMONIC SCALPEL WAS USED IN DIVISION OF THE VASCULAR SUPPLY OF THE GASTRIC GREATER CURVATURE UNTIL THE ANGLE OF HIS. IN SOME PATIENTS, SG WAS CREATED USING ECHELON ENDOPATH WITH GOLD CARTRIDGE. IN GROUP 1, THE RESECTED STOMACH WAS EXTRACTED IN A RETRIEVAL BAG USING AN ENDOLOOP AROUND ONE EXTREMITY TO FACILITATE REMOVAL. POSTOPERATIVE COMPLICATION INCLUDED POSTOPERATIVE BLEEDING (N=13) IN WHICH FOUR HAD MELENA AND ONE HAD HEMATEMESIS (SHOWED BLEEDING FROM THE INNER SIDE OF THE STAPLE LINE), AND WERE TREATED CONSERVATIVELY IN (N=11) AND 1-5 UNITS BLOOD TRANSFUSION WAS REQUIRED IN 9 PATIENTS. THE OTHER TWO CASES REQUIRED REOPERATION: IN ONE CASE A RETROGASTRIC VESSEL, RESPONSIBLE FOR THE BLEEDING WAS CLIPPED BY LAPAROSCOPY; IN THE OTHER CASE A LAPAROTOMY WAS PERFORMED. OTHER COMPLICATION INCLUDED STAPLER LINE LEAK (N=9) TREATED WITH BAND REVISION (N=1) AND NON-OPERATIVE TREATMENT OF PERCUTANEOUS DRAINAGE, ENDOSCOPY AND STENTS IN ALL PATIENTS. IN ONE CASE FOR PERSISTENCE OF THE LEAK AFTER CONSERVATIVE TREATMENT AND STENTS PLACEMENT, A RESCUE REOPERATION WAS PERFORMED (ESOPHAGO-JEJUNOSTOMY) 4 MONTHS AFTER SG. AFTER LAPAROTOMY, AN UPPER GASTRECTOMY SAVING THE GASTRIC ANTRUM WAS PERFORMED. THE ESOPHAGO-JEJUNOSTOMY WAS PERFORMED USING A 21-MM CIRCULAR STAPLER AND REINFORCED WITH SEPARATED STITCHES. THE OPERATIVE OPTION WAS CHOSEN MAINLY FOR THE ABSOLUTE NONCOMPLIANCE OF THE PATIENT TO MAINTAIN THE FAST. THE PATIENT DIED ON THIRD POSTOPERATIVE DAY AS A RESULT OF ACUTE CANDIDIASIS SEPSIS ON ICU. IN 3 PATIENTS, ABDOMINAL ABSCESS WAS FOUND. SG IS A SAFE AND EFFECTIVE TREATMENT FOR MORBID OBESITY AT MID-TERM FOLLOW-UP. SG IS EFFECTIVE ON COMORBIDITIES RESOLUTION, ESPECIALLY FOR THE TREATMENT OF DIABETES. LEARNING CURVE AND SURGICAL SKILL PLAY AN IMPORTANT ROLE IN THE INCIDENCE OF MAJOR COMPLICATIONS AND OPERATIVE TIME. SUTURE LINE REINFORCEMENT ALLOWS A SIGNIFICANT REDUCTION OF BLEEDING BUT DOES NOT DECREASE THE OCCURRENCE OF LEAKS WHICH REMAIN A MAJOR PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9341 FLEX 60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036001706

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention