BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 24765634 · Received April 2, 2026

    Report

    Report Number
    3005075853-2026-02456
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    July 21, 2025
    Report Date
    April 2, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IT WAS REPORTED VIA JOURNAL ARTICLE: DATE SENT: 4/2/2026. D4: BATCH # UNK. 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: THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LAINAS P, KASSIR R, TRIANTAFYLLOU E, DAMMARO C, SAFIEDDINE M, DEVAQUET N, DAGHER I. EVALUATION OF COMPLETE GASTRIC STAPLE LINE BIOABSORBABLE REINFORCEMENT DURING LAPAROSCOPIC SLEEVE GASTRECTOMY: A PROPENSITY SCORE MATCHED ANALYSIS. UPDATES SURG. 2025 NOV;77(7):2087-2095. DOI: 10.1007/S13304-025-02326-7. EPUB 2025 JUL 21. PMID: 40691393. THE AIM OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF COMPLETE GASTRIC STAPLE LINE BIOABSORBABLE REINFORCEMENT TO MINIMIZE SURGICAL COMPLICATIONS IN PATIENTS UNDERGOING LSG BETWEEN JANUARY 2013 AND DECEMBER 2022 `. PATIENTS WERE DIVIDED INTO TWO GROUPS: SLR-LSG GROUP (STAPLE LINE REINFORCEMENT GROUP) (N=439) & C-LSG GROUP (CONTROL GROUP / NO REINFORCEMENT GROUP) (N=439). ECHELON FLEX (EES) WAS USED IN THE TRANSECTION OF THE STOMACH. REPORTED COMPLICATIONS: ECHELON FLEX (EES). C-LSG GROUP (N=439). EARLY POST-OP COMPLICATIONS (N=52). TREATMENT: NOT REPORTED. INTRAABDOMINAL BLEEDING/HEMATOMA (N=17). TREATMENT: 11 REQUIRED RE-LAPAROSCOPY AND 6 WERE MANAGED CONSERVATIVELY BY ANTICOAGULATION DISCONTINUATION AND MONITORING; 6 PATIENTS REQUIRED BLOOD TRANSFUSION. GASTRIC STAPLE LINE LEAK (N=15). TREATMENT: 8 REQUIRED RE-LAPAROSCOPY AND ANTIBIOTIC THERAPY, 5 WERE TREATED BY RE-LAPAROSCOPY COUPLED TO EARLY ENDOSCOPIC TREATMENT AND ANTIBIOTIC THERAPY, AND 2 WERE MANAGED BY ENDOSCOPIC INTERNAL DRAINAGE COUPLED TO ANTIBIOTIC THERAPY. NON-SUGRICAL COMPLICATIONS (N=20). TREATMENT: NOT REPORTED. READMISSION (N=9). TREATMENT: NOT REPORTED. SLR-LSG (N=439). EARLY POST-OP COMPLICATIONS (N=12). TREATMENT: NOT REPORTED. GASTRIC STAPLE LINE LEAKAGE (N=6). TREATMENT: TWO REQUIRED RE-LAPAROSCOPY AND ANTIBIOTIC THERAPY, AND FOUR WERE TREATED BY ENDOSCOPIC INTERNAL DRAIN AGE COUPLED TO ANTIBIOTIC THERAPY. NON-SURGICAL COMPLICATIONS (N=6). TREATMENT: NOT REPORTED READMISSION (N=6). TREATMENT: NOT REPORTED. IN CONCLUSIONS, COMPLETE GASTRIC STAPLE LINE BIOABSORBABLE REINFORCEMENT COMBINED WITH PERIOPERATIVE ARTERIAL HYPERTENSION CONTROL SIGNIFICANTLY REDUCES BLEEDING, REOPERATION RATES, AND HOSPITAL STAY LENGTH, WHILE SHOWING A NON-SIGNIFICANT REDUCTION IN GASTRIC STAPLE LINE LEAK RATES IN PATIENTS WITH SEVERE OBESITY UNDERGOING LSG. PROSPECTIVE RANDOMIZED STUDIES SHOULD BE PERFORMED IN PATIENTS WITH SEVERE OBESITY UNDERGOING LSG TO VALIDATE THIS TECHNIQUE AS GOLD STANDARD PRACTICE IN BARIATRIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828680 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R