BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN)

    MDR report key: 22363591 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04872
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    January 1, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 06/30/2025. D4: BATCH #UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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. H4: THE DEVICE MANUFACTURE DATE IS CURRENTLY NOT AVAILABLE. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED. 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. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. 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

    TITLE: APPLICATION OF UNIDIRECTIONAL BARBED SUTURE IN RADICAL GASTRECTOMY FOR GASTRIC CANCER. AUTHOR: ZHANG XINFENG, ZHANG XIAOLI, TIAN YAN, LUO HUAYU, LEI YI. CITATION: CHIN J CLIN ONCOL REHABIL, NOVEMBER 2021, VOL 28, NO. 11. [DOI] 10. 13455/J. CNKI. CJCOR. 2021. 11. 06. THIS STUDY AIMS TO INVESTIGATE THE SAFETY AND EFFICACY OF UNIDIRECTIONAL BARBED SUTURE IN RADICAL GASTRECTOMY FOR GASTRIC CANCER, PROVIDING A REFERENCE FOR THE CLINICAL USE OF UNIDIRECTIONAL BARBED SUTURE. FROM JANUARY 2019 TO DECEMBER 2019, 45 PATIENTS WHO UNDERWENT ENDOSCOPE-ASSISTED RADICAL GASTRECTOMY + BILLROTH I AND CONTINUOUS SUTURE OF GASTROINTESTINAL ANASTOMOSIS WITH UNIDIRECTIONAL BARBED SUTURE IN THE FIRST AFFILIATED HOSPITAL OF KUNMING MEDICAL UNIVERSITY WERE SELECTED AS THE BARBED LINE GROUP, AND ANOTHER PATIENTS WERE SELECTED AS THE SAME ,A TOTAL OF 45 PATIENTS WHO RECEIVED ROUTINE ABSORBABLE SUTURE FOR INTERRUPTED SUTURE OF GASTROINTESTINAL ANASTOMOSIS WERE SELECTED AS CONTROL GROUP.DURING SURGERY, THE TUMOR WAS PARTIALLY CUT BY WAKE GUN AND BLUE NAIL LINEAR CUTTER STAPLER, SEALING THE GREATER CURVATURE SIDE OF THE STOMACH, IRRIGATE STOMACH WITH IODOPHOR DISTILLED WATER. PLACEMENT OF J & J 25 MM ANASTOMOTIC HANDLE FOR ANASTOMOSIS BETWEEN GREATER CURVATURE OF STOMACH AND DUODENUM WAS DONE. BARBED SUTURE GROUP PATIENT USE 4 -0 UNIDIRECTIONAL ABSORBABLE BARBED SUTURE WAS USED TO SUTURE GASTROINTESTINAL ANASTOMOSIS AND INCISAL EDGE OF STOMACH, USE IN CONTROL PATIENTS 4 -0 ABSORBABLE BROWNIAN SUTURE WAS USED TO SUTURE GASTROINTESTINAL ANASTOMOSIS AND INCISAL MARGIN OF STOMACH. REPORTED COMPLICATIONS INCLUDED: (N=1) ILEUS, (N=?) ANASTOMOTIC LEAKAGE, (N=?) ANASTOMOTIC BLEEDING, AND (N=?) ANASTOMOTIC STENOSIS. IT WAS CONCLUDED THAT APPLICATION OF UNIDIRECTIONAL BARBED CONTINUOUS SUTURE IN ANASTOMOSIS SUTURE OF RADICAL GASTRECTOMY FOR GASTRIC CANCER, MAY REDUCE OPERATIVE TIME, ANQUAN EFFECTIVE. AND SUTURE REPAIR OF GASTROINTESTINAL ANASTOMOSIS DID NOT SIGNIFICANTLY INCREASE HOSPITALIZATION COSTS OF PATIENTS IN BARBED SUTURE GROUP, IT CAN BE SUTURED ACCORDING TO THE PATIENT'S WISHES AND THE DOCTOR'S TECHNIQUE, DECIDE WHETHER TO APPLY IN CLINICAL PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368509 ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other