BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 24818011 · Received April 8, 2026

    Report

    Report Number
    3005075853-2026-02641
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    October 3, 2025
    Report Date
    April 8, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/8/2026 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: VLADIMIROV M, POUWELS S, KEMETER M, GOYAL A, HÖPPNER J, STEIN H, OVIEDO RJ. ROBOTIC HAND-SEWN VERSUS LINEAR-STAPLED GASTROJEJUNOSTOMY IN ROBOTIC ROUX-EN-Y GASTRIC BYPASS FOR PRIMARY AND REVISIONAL METABOLIC AND BARIATRIC SURGERY: GERMAN EXPERIENCE FROM A SINGLE CENTER STUDY. OBES SURG. 2025 DEC;35(12):5047-5053. DOI: 10.1007/S11695-025-08243-3. EPUB 2025 OCT 3. PMID: 41042298. THIS STUDY EVALUATES CLINICAL OUTCOMES OF ROBOTIC HAND-SEWN VERSUS LINEAR-STAPLED GJ ANASTOMOSIS IN PRIMARY AND REVISIONAL METABOLIC AND BARIATRIC SURGERY (MBS). THIS RETROSPECTIVE STUDY EVALUATED 64 CONSECUTIVE PATIENTS WITH SEVERE OBESITY WHO UNDERWENT ROBOTIC ROUX-EN-Y GASTRIC BYPASS (RYGB) USING THE DA VINCI XI SYSTEM (INTUITIVE SURGICAL, INC., SUNNYVALE, CA, USA) AT A SINGLE CENTER BY ONE SURGEON BETWEEN JANUARY 1, 2021, AND DECEMBER 31, 2023. THE BILIOPANCREATIC AND ALIMENTARY (ROUX) LIMBS WERE MEASURED BETWEEN 80 AND 150 CM IN LENGTH. GASTROJEJUNOSTOMY (GJ) ANASTOMOSES WERE CREATED WITH LINEAR STAPLERS IN 40 CASES, 10 USING THE DA VINCI ROBOTIC STAPLER WITH A BLUE CARTRIDGE (TOTALLY ROBOTIC PROCEDURE) AND 30 USING THE ECHELON POWERED STAPLER WITH A GOLD CARTRIDGE (HYBRID ROBOTIC PROCEDURE). THE JEJUNOJEJUNOSTOMY (JJ) WAS CONSTRUCTED USING EITHER A ROBOTIC LINEAR STAPLER WITH A BLUE CARTRIDGE (N=10), AN ECHELON LAPAROSCOPIC POWERED STAPLER WITH A GOLD CARTRIDGE (N=28), OR ENTIRELY ROBOTICALLY HAND-SEWN (N=25) WITH A CONTINUOUS BARBED SUTURE (V-LOC®). IN STAPLED JJ CASES, THE COMMON ENTEROTOMY WAS CLOSED ROBOTICALLY USING BARBED SUTURES. ALL MESENTERIC DEFECTS WERE ROUTINELY CLOSED WITH CONTINUOUS ROBOTIC SUTURING USING PERMANENT SUTURE MATERIAL. REPORTED COMPLICATIONS INCLUDE: ECHELON POWERED STAPLER (ETHICON) LEAK AT THE VERTICAL STAPLE LINE (N=1) TREATMENT: CONVERSION TO OPEN SURGERY FUNCTIONAL STENOSIS (N=2) TREATMENT: REOPERATION POSTOPERATIVE EXTRALUMINAL BLEEDING (N=1) TREATMENT: MANAGED LAPAROSCOPICALLY BY CLIPPING SURGICAL SITE INFECTION (N=2) TREATMENT: NOT REPORTED IN CONCLUSION, ROBOTIC RYGB USING EITHER HAND-SEWN OR STAPLED GASTROJEJUNOSTOMY TECHNIQUES CAN BE SAFELY EXECUTED IN AN ACCREDITED MBS REFERRAL CENTER. THE FULLY ROBOTIC APPROACH FACILITATES THE USE OF HAND-SEWN ANASTOMOSES IN BOTH PRIMARY AND REVISIONAL SETTINGS. THE OCCURRENCE OF ANASTOMOTIC STENOSES IN THE HAND-SEWN GROUP IS LIKELY ATTRIBUTABLE TO THE INITIAL LEARNING CURVE. THE MENTION OF LINX® DEVICE IN THIS ARTICLE REFERS TO THE USE FOR REFLUX DISEASE WHICH WAS IMPLANTED PRE-OPERATIVELY. THUS, EXCLUDED. MORTALITY MENTIONED IN THIS ARTICLE REFERS TO THE PATIENT WHO HAD PULMONARY EMBOLISM. PNEUMONIA AND MARGINAL ULCER WERE NOT RELATED TO THE USE OF ECHELON POWERED STAPLER (ETHICON). THUS, EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874926 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention