BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9970607 · Received April 16, 2020

    Report

    Report Number
    2210968-2020-03119
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Report Date
    March 23, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: ALL INFORMATION REQUESTED ARE UNKNOWN. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE COMPLAINT REFERENCE NUMBERS. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS: VICRYL ABSORBABLE SUTURE, INVOLVED CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE, SPECIFICALLY: PERITONEAL TEARING AND SUTURE LINE BREAKING? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH 2020;30:18¿21. (B)(4).

    Description of Event or Problem · 1

    TITLE: A NEW SUTURE TECHNIQUE FOR PERITONEAL FLAP CLOSURE IN TAPP: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL. THIS PROSPECTIVE RANDOMIZED CONTROLLED TRIAL AIMED TO EVALUATE THE EFFICACY OF THE NEW SUTURE METHOD FOR LAPAROSCOPIC CLOSURE OF THE PERITONEAL FLAP IN TRANSABDOMINAL PREPERITONEAL (TAPP)COMPARED WITH THE CONVENTIONAL METHOD. IN (B)(6) 2019, 80 PATIENTS WITH PRIMARY UNILATERAL INGUINAL HERNIA WERE RANDOMIZED INTO THE CONVENTIONAL SUTURE METHOD GROUP AND THE NEW SUTURE GROUP FOR TAPP. IN THE PROCEDURE, BOTH TECHNIQUES UTILIZED 3-0 VICRYL ABSORBABLE SUTURE IN PERITONEAL FLAP CLOSURE. OUTCOMES INCLUDED PERITONEAL TEARING (N=15; N=11 CONVENTIONAL GROUP AND N=4 NEW SUTURE GROUP); AND SUTURE LINE BREAKING (N=11; N=8 CONVENTIONAL GROUP AND N=3 NEW SUTURE GROUP). TRADITIONALLY, THE PERITONEUM SUTURE IS STARTED BY SUTURING THE PERITONEUM VERTICALLY; IN CASE THE PERITONEUM IS VERY THIN, THE VERTICAL SUTURE FORCE OF THE NEEDLE AND THE VERTICAL PASSAGE OF THE SUTURE MATERIAL WOULD TEAR THE UPPER FLAP OF THE PERITONEUM, AND THIS COULD BE SEEN FROM OUR OBSERVATIONS. THIS NEW SUTURE METHOD IS EASY TO PERFORM, IS ASSOCIATED WITH REDUCED SUTURE TIME, AND CAUSES LESS PERITONEAL TEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430272 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1