BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19086331 · Received April 11, 2024

    Report

    Report Number
    2210968-2024-04187
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    January 1, 2022
    Report Date
    April 11, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-04186 AND 2210968-2024-04188. CITATION: BARIATRIC SURGICAL PRACTICE AND PATIENT CARE (2022);17(1):23-28. HTTPS://DOI.ORG/10.1089/BARI.2020.0133.

    Description of Event or Problem · 0

    TITLE: MODIFIED OMENTOPEXY IN LAPAROSCOPIC SLEEVE GASTRECTOMY: DOES IT REDUCE THE RISK OF POSTOPERATIVE COMPLICATIONS? THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE EFFECTIVENESS OF MODIFIED OMENTOPEXY (MOP) ADDED TO LSG IN REDUCING POSTOPERATIVE COMPLICATIONS. BETWEEN DECEMBER 2012 AND MARCH 2020, A TOTAL OF 567 MORBID OBESITY PATIENTS WHO UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: GROUP A OF 180 LSG PATIENTS WITH MODIFIED OMENTOPEXY (MOP), AND GROUP B OF 387 LSG PATIENTS WHERE NO OMENTOPEXY (OP) WAS DONE. THE MEAN AGE WAS 36.8±11.1 YEARS AND 72.8% OF THE POPULATION WAS WOMEN. THE MEAN PREOPERATIVE BMI WAS 45.3±7.4 KG/M2. IN THE MOP GROUP, THE OMENTUM WAS SUTURED TO THE NEW GREATER CURVATURE OF THE STOMACH AT TWO DIFFERENT POINTS IN THE CORPUS AND ANTRUM WITH USING ABSORBABLE 2.0 VICRYL SUTURES. REPORTED COMPLICATIONS INCLUDE SYMPTOMATIC STENOSIS DUE TO GASTRIC TWIST (N=3). IN CONCLUSION, OP, WHICH WE CREATED WITH OUR OWN TECHNICAL MODIFICATION IN LSG, DID NOT REDUCE THE RISK OF POSTOPERATIVE COMPLICATIONS. ON THE CONTRARY, THESE PATIENTS WERE FOUND TO HAVE AN INCREASED RISK OF GASTRIC TWIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447064 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention