BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 16594100 · Received March 22, 2023

    Report

    Report Number
    2210968-2023-01932
    Event Type
    Injury
    Date Received
    March 22, 2023
    Date of Event
    December 24, 2022
    Report Date
    March 22, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. 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 2210968-2023-01931. CITATION CITE: OBESITY SURGERY (2023) 33:506¿512 HTTPS://DOI.ORG/10.1007/S11695-022-06411-3.

    Description of Event or Problem · 0

    TITLE: EFFECT OF SUTURE USED FOR CLOSURE OF MESENTERIC DEFECTS AFTER LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS: SINGLE-CENTER STUDY. THE OBJECTIVE OF THIS STUDY IS TO EVALUATE DIFFERENT TYPES OF NON-ABSORBABLE SUTURES USED FOR CLOSURE OF THE DEFECTS REGARDING THE INCIDENCE OF SBO DUE TO IH/ADHESIONS, ADHESION FORMATION IN GENERAL, OR REOPENING OF THE DEFECTS. A SINGLE-CENTER RETROSPECTIVE STUDY WAS PERFORMED. PATIENTS WHO UNDERWENT LRYGBP WERE DIVIDED IN 3 GROUPS: GROUP A CLOSURE OF THE DEFECTS WITH MONOFILAMENT POLYPROPYLENE SUTURE (PROLENE), GROUP B WITH BRAIDED POLYESTER SUTURE (ETHIBOND), GROUP C WITH BARBED KNOTLESS POLYBUTESTER SUTURE (V-LOC). REPORTED COMPLICATIONS INCLUDED SMALL BOWEL OBSTRUCTION (N=52 ), ADHESION (N=61), INTERNAL HERNIATION (N= 35 ), ABDOMINAL PAIN (N=?) , PAIN (N=15), NAUSEA AND VOMITING (N=9) IN CONCLUSION AFTER DESCRIPTIVE ANALYSIS, THESE RESULTS CAN WITHHOLD NO DIFFERENCE AMONG THE 3 NON-ABSORBABLE SUTURES REGARDING THE INCIDENCE OF SBO DUE TO IH OR ADHESIONS, YET TENDENCY FOR HIGHER REOPENING RATES AFTER CLOSURE WITH MONOFILAMENT POLYPROPYLENE SUTURE IS OBSERVED. MORE STUDIES ARE NEEDED TO EVALUATE OPTIMAL CLOSURE TECHNIQUE AND MATERIAL FOR MESENTERIC DEFECTS DURING LRYGBP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455630 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other