BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 15027811 · Received July 15, 2022

    Report

    Report Number
    2210968-2022-05539
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    January 18, 2022
    Report Date
    July 27, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PC-(B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. 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. 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 NUMBER HAS NOT BEEN PROVIDED. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-05536, 2210968-2022-05537, 2210968-2022-05538, 2210968-2022-05540, 2210968-2022-05541, 2210968-2022-05542. CITATION: HTTPS://DOI.ORG/10.1155/2022/4494401.

    Description of Event or Problem · 0

    TITLE: A MODIFIED ANASTOMOSIS TECHNIQUE FOR ESOPHAGOJEJUNOSTOMY AFTER LAPAROSCOPY-ASSISTED TOTAL GASTRECTOMY: A SINGLE TEAM PRELIMINARY EXPERIENCE THIS RETROSPECTIVE STUDY AIMED AT SHARING THE AUTHOR'S EXPERIENCE OF THIS MODIFIED ANASTOMOSIS TECHNIQUE FOR LATG AND TO COMPARE IT WITH CONVENTIONAL ROUX-EN-Y ESOPHAGOJEJUNOSTOMY. A TOTAL OF 112 PATIENTS WHO HAD UNDERGONE LAPAROSCOPIY-ASSISTED TOTAL GASTRECTOMY (LATG) WITH D2 LYMPHADENECTOMY WERE EXAMINED BETWEEN JANUARY 2016 AND DECEMBER 2020. OF THESE, 44 PATIENTS (29 MALE AND 15 FEMALE; MEAN AGE OF 62:3 ± 9:1 YEARS) RECEIVED A CONVENTIONAL ROUX-EN-Y END-TO-SIDE ESOPHAGOJEJUNOSTOMY (CRY) GROUP, AND THE REMAINING 68 PATIENTS (41 MALE AND 27 FEMALE; MEAN AGE OF 65:2 ± 7:9 YEARS) UNDERWENT PANT-SHAPED ROUX-EN-Y ESOPHAGOJEJUNOSTOMY (PRY). THE SURGERY WAS PERFORMED USING A LINEAR STAPLER (ECHELON 60; ETHICON ENDO-SURGERY), A COMPETITOR'S CIRCULAR STAPLER, 3-0 VICRYL SUTURE (ETHICON, CINCINNATI, USA). REPORTED COMPLICATIONS INCLUDE POSTOPERATIVE BLEEDING (N=2); ANASTOMOTIC LEAKAGE (N=3) IN CASES 5, 6, 7 WHICH WAS SUCCESSFULLY TREATED BY CONSERVATIVE TREATMENT, INCLUDING ABDOMINAL DRAINAGE, ENTERAL NUTRITION, AND ANTIBIOTICS IN CASE 5, WHILE IN CASES 6 AND 7, REOPERATIONS WERE CARRIED OUT DUE TO FAILURE OF DRAINAGE; ANASTOMOTIC STENOSIS WITH EARLY DYSPHAGIA (N=4) IN CASES 1, 2, 3, AND 4 WHO WERE ADDRESSED WITH SEVERAL TIMES OF ENDOSCOPIC BALLOON DILATION. IN CONCLUSION, THE APPLICATION OF PANT-SHAPED ANASTOMOSIS FOR ESOPHAGOJEJUNOSTOMY AFTER LTG IS A SAFE AND FEASIBLE PROCEDURE AND HAS AN ADVANTAGE WHEN THE JEJUNUM DIAMETER IS SMALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2756516 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention