BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 21514039 · Received March 4, 2025

    Report

    Report Number
    3005075853-2025-01710
    Event Type
    Injury
    Date Received
    March 4, 2025
    Date of Event
    May 24, 2024
    Report Date
    March 4, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/4/2025. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: MARGINAL ULCER PERFORATION AFTER ONE ANASTOMOSIS GASTRIC BYPASS: SURGICAL TREATMENT AND TWO-YEAR OUTCOMES AUTHORS: ADAM ABU-ABEID 1, ADI LITMANOVICH 1, JONATHAN BENJAMIN YUVAL 1, JAWAD TOME 1, ANDREI KEIDAR 1, SHAI MERON ELDAR 1. CITATION: J CLIN MED. 2024 MAY 24;13(11):3075. DOI: 10.3390/JCM13113075. THE AIM OF THIS STUDY WAS TO ANALYZE THE TWO-YEAR OUTCOMES OF PATIENTS UNDERGOING SURGICAL REVISION DUE TO MU PERFORATION AFTER OAGB. BETWEEN JANUARY 2015 TO DECEMBER 2023, ALL PATIENTS UNDERGOING REVISIONAL SURGERY DUE TO MU PERFORATION AFTER OAGB WERE INCLUDED AND ANALYZED IN THIS STUDY. THE DATA REGARDING OAGB CHARACTERISTICS WERE CAPTURED AND INCLUDED AGE, SEX, BASELINE BODY MASS INDEX (BMI), SMOKING, SEVERE OBESITY RELATED DISEASES INCLUDING TYPE 2 DIABETES, HYPERTENSION, OBSTRUCTIVE SLEEP APNEA, HYPERLIPIDEMIA, AND NON-ALCOHOLIC FATTY LIVER DISEASE. DATA REGARDING PREVIOUS BARIATRIC PROCEDURES, INCLUDING THE PROCEDURE TYPE, WERE ALSO CAPTURED. ADDITIONAL DATA THAT WERE CAPTURED, WHEN AVAILABLE, INCLUDED THE BILIOPANCREATIC LIMB LENGTH IN THE OAGB. DURING THE CORRESPONDING PERIOD, 22 PATIENTS UNDERWENT SURGICAL REVISION DUE TO A MU PERFORATION AFTER OAGB, AMONG WHICH 15 PATIENTS UNDERWENT OAGB IN OUR CENTER, WHICH ACCOUNTS FOR A 0.98% RATE OF MU PERFORATION (15/1522). THE BASELINE CHARACTERISTICS OF THE PATIENTS PRIOR TO OAGB ARE SHOWN IN TABLE 1¿THE MEDIAN AGE WAS 48.6 (IQR¿23.4), THERE WERE 13 MEN (59%), AND THE MEDIAN BMI PRIOR TO OAGB WAS 38 (IQR¿6.9). THE MEDIAN BILIOPANCREATIC LIMB LENGTH WAS 195 CM. THERE WERE 11 PATIENTS (50%) WHO WERE SMOKERS, 5 PATIENTS (23%) WHO HAD A PREOPERATIVE HP ERADICATION (THE REST WERE NEGATIVE), AND 8 PATIENTS (36%) WHO UNDERWENT A PREVIOUS BARIATRIC PROCEDURE INCLUDING SLEEVE GASTRECTOMY (N = 5) AND LAPAROSCOPIC ADJUSTABLE GASTRIC BAND (N = 3). ALL PROCEDURES WERE PERFORMED AFTER THE ADMINISTRATION OF VENOUS THROMBOEMBOLISM PROPHYLAXIS (SUBCUTANEOUS INJECTION OF HEPARIN 5000 UNITS, 2 H BEFORE INCISION) AND ANTIBIOTIC PROPHYLAXIS (INTRAVENOUS CEPHAZOLIN 2¿3 G, BEFORE INCISION). THE PATIENTS WERE PLACED UNDER GENERAL ANESTHESIA, IN THE SUPINE POSITION AND REVERSE TRENDELENBURG. A SIDE-TO-SIDE GASTRO¿JEJUNAL ANASTOMOSIS WAS CREATED BETWEEN THE LATERAL GASTRIC POUCH WALL TO THE SMALL BOWEL USING AN ENDO-STAPLER-ECHELON BLUE CARTRIDGE (ETHICON ENDO-SURGERY INC., CINCINNATI, OH, USA) OR END-GIA PURPLE CARTRIDGE (COVIDIEN/MEDTRONIC INC., MINNEAPOLIS, MN, USA). REPORTED COMPLICATIONS ARE MARGINAL ULCER (MU) PERFORATION (N=?) AND BILIARY REFLUX (N=?). IN CONCLUSION, MU PERFORATIONS WERE NOT SHOWN TO BE EXTREMELY RARE IN OUR EXPERIENCE (0.98%). IN OUR SERIES, MOST PATIENTS WERE MALE, EXPERIENCED AN ANTERIOR PERFORATION, AND WERE TREATED EFFECTIVELY WITH AN OMENTAL PATCH. RECURRENT MU RATES AT 2-YEAR FOLLOW-UP WERE REASONABLE AND IN THE RANGE OF ACCEPTABLE RATES. FURTHER LARGE-SCALE AND PROSPECTIVE STUDIES ARE NEEDED TO DEFINE THE PREVALENCE OF MU IN OAGB AND TO COMPARE THE PREVALENCE OF MU BETWEEN DIFFERENT MBS PROCEDURES (ESPECIALLY RYGB).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585377 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention