BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 12249660 · Received July 29, 2021

    Report

    Report Number
    3005075853-2021-04259
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    January 1, 2020
    Report Date
    July 2, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/8/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? NO ¿ THE SURGEONS DO NOT BELIEVE THAT THE ETHICON DEVICES CONTRIBUTED TO THE REPORTED EVENTS. UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2020. BATCH #: UNKNOWN. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    TITLE: SHORT- TO MEDIUM-TERM RESULTS OF SINGLE-ANASTOMOSIS DUODENO-ILEAL BYPASS COMPARED WITH ONE-ANASTOMOSIS GASTRIC BYPASS FOR WEIGHT RECIDIVISM AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY AUTHORS: MARLON DE LA CRUZ, M.D., MARTIN BÜSING, M.D., RADOSTINA DUKOVSKA, M.D., ANTONIO JOSÉ TORRES, M.D., PH.D., MARKUS REISER, M.D. CITATION: SURGERY FOR OBESITY AND RELATED DISEASES (2020); 16: 1060¿1066. DOI: HTTPS://DOI.ORG/10.1016/J.SOARD.2020.04.014. THE AIM OF THIS OBSERVATIONAL STUDY IS TO EVALUATE THE EFFICACY AND SAFETY OF SADI AND OAGB AS REVISIONAL BARIATRIC SURGERY (RBS) IN INITIALLY SUPER-OBESE PATIENTS (BODY MASS INDEX [BMI] .50 KG/M2). BETWEEN JULY 2013 AND APRIL 2018, A TOTAL OF 84 INITIALLY SUPER-OBESE PATIENTS UNDERWENT RBS AFTER LSG. OF THESE, 42 PATIENTS (31 FEMALE, 11 MALE; MEAN AGE = 45.1±11.1 YEARS; MEAN BMI = 55.1±12 KG/M2) UNDERWENT A SADI PROCEDURE, IN THE OTHER 42 PATIENTS (28 FEMALE, 14 MALE; MEAN AGE = 47.2±10.8 YEARS; MEAN BMI = 55.6±9.1 KG/M2) AN OAGB WAS PERFORMED. THE SINGLE-ANASTOMOSIS DUODENO-ILEAL BYPASS (SADI) PROCEDURE WAS PERFORMED USING A 60-MM BLUE CARTRIDGE LINEAR STAPLER (ECHELON FLEX; ETHICON). THE ONE-ANASTOMOSIS GASTRIC BYPASS (OAGB) PROCEDURE WAS PERFORMED USING A 60-MM LINEAR STAPLER (ECHELON FLEX; ETHICON) AND THE CLOSURE OF THE STAPLER ENTRY POINTS WAS PERFORMED THROUGH A 3.0 PDS CONTINUOUS SUTURE (ETHICON). REPORTED COMPLICATIONS INCLUDED WOUND INFECTION/HEALING DISORDER (N=4); OBSTIPATION (N=7); FLATULENCE (N=6); DIARRHEA (N=10); STEATORRHEA (N=5); PAIN, NAUSEA, BLOATEDNESS (N=15); SYMPTOMATIC BILE REFLUX (N=13); ANASTOMOTIC ULCERS (N=1); MASSIVE MALABSORPTION SYNDROME (N=3); DUMPING SYNDROME (N=6); READMISSION (N=28); ABSCESS (N=3); STAPLE LINE LEAK (N=2); DUODENAL STUMP INSUFFICIENCY (N=1) AND ANASTOMOSIS LEAK (N=1) WHICH WERE MANAGED BY LAPAROSCOPIC INTERVENTIONS WITH UNEVENTFUL FOLLOW-UP; SMALL BOWEL PERFORATION (N=1) 80 CM POSTTREITZ CAUSED BY AN INCARCERATED INTERNAL HERNIA (N=1) WHICH REQUIRED MULTIPLE SURGICAL REVISIONS LEADING TO A PROLONGED HOSPITAL STAY; INCISIONAL HERNIA (N=4); AND A FEMALE PATIENT SUFFERED A SMALL BOWEL PERFORATION (N=1) 11 CM FROM THE GASTROJEJUNAL ANASTOMOSIS, WHICH WAS SUCCESSFULLY OVERSTITCHED WITHOUT FURTHER COMPLICATIONS. IN CONCLUSION, BOTH SADI AND OAGB WERE EFFECTIVE PROCEDURES TO ADDRESS WEIGHT RECIDIVISM AFTER LSG IN A COHORT OF INITIALLY SUPER-OBESE DIFFICULT TO TREAT PATIENTS. WEIGHT LOSS, PROCEDURAL TIME, AND COMPLICATION RATES WERE COMPARABLE. GERD SYMPTOMS IMPROVED IN BOTH TREATMENT GROUPS PROVIDING AN ADDITIONAL BENEFIT FOR PATIENTS WITH PERSISTING REFLUX SYMPTOMS AFTER LSG. ANATOMIC AND PHYSIOLOGIC IMPACT IS SUBSTANTIAL FOR BOTH SADI AND OAGB. CONSEQUENT LIFELONG SUPPLEMENTATION OF MICRONUTRIENTS AND LONG-TERM MEDICAL CARE ARE MANDATORY TO PREVENT LONG-TERM COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143504 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention