BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7916419 · Received September 27, 2018

    Report

    Report Number
    2210968-2018-76122
    Event Type
    Injury
    Date Received
    September 27, 2018
    Report Date
    September 3, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: MEDICINE. 2016; 95: 39(E4981). DOI: DX.DOI.ORG/10.1097/MD.0000000000004981 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: BARBED VERSUS CONVENTIONAL 2-LAYER CONTINUOUS RUNNING SUTURES FOR LAPAROSCOPIC VAGINAL CUFF CLOSURE" AUTHORS: JIN HWI KIM, MD, PHD; SEUNG WON BYUN, MD; JAE YEON SONG, MD, PHD; YEON HEE KIM, MD, PHD; HEE JOONG LEE, MD, PHD; TAE CHUL PARK, MD, PHD; KEUN HO LEE, MD, PHD; SOO YOUNG HUR, MD, PHD; JONG SUP PARK, MD, PHD; SUNG JONG LEE, MD, PHD CITATION: MEDICINE. 2016; 95: 39(E4981). DOI: DX.DOI.ORG/10.1097/MD.0000000000004981. THE AUTHORS COMPARED RESULTS USING UNIDIRECTIONAL BARBED SUTURES AND CONVENTIONAL SUTURES FOR VAGINAL CUFF CLOSURE DURING TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH). THE ELECTRONIC MEDICAL RECORDS AND SURGICAL VIDEOS OF 170 PATIENTS WHO UNDERWENT TLH BETWEEN JANUARY 2013 AND MARCH 2015 AT (B)(6) WERE REVIEWED. V-LOC SUTURES WERE USED IN 64 PATIENTS AND VICRYL SUTURES (ETHICON) WERE USED IN 106 PATIENTS (MEAN AGE: 46.9 YEARS; BMI: 24.4). IN ALL PATIENTS, ALL LAPAROSCOPIC HYSTERECTOMIES WERE PERFORMED FOLLOWING STANDARD METHODS USING ADVANCED ENSEAL BIPOLAR (ETHICON) AND MONOPOLAR ELECTROCAUTERY. AFTER REMOVAL OF THE UTERUS, NEEDLES WERE INTRODUCED THROUGH THE UMBILICAL TROCAR, AND THE VAGINA WAS CLOSED WITH A 2-LAYER RUNNING SUTURE USING VICRYL 1-0 SUTURES (ETHICON) OR V-LOC. THEN THE NEEDLES WERE REMOVED THROUGH THE PERIPHERAL TROCARS. IN THE V-LOC GROUP, REPORTED COMPLICATIONS INCLUDED BLEEDING (N-2) WHICH WERE TREATED CONSERVATIVELY AND POST-OPERATIVE FEVER (N-6) WHICH WERE TREATED CONSERVATIVELY. IN THE VICRYL GROUP, REPORTED COMPLICATIONS INCLUDED BLEEDING (N-8) WHICH WERE TREATED CONSERVATIVELY, INFECTION (N-2) WHICH WERE TREATED CONSERVATIVELY, AND POST-OPERATIVE FEVER (N-8) WHICH WERE TREATED CONSERVATIVELY. THE AUTHORS DEMONSTRATED THAT THE USE OF UNI-DIRECTIONAL BARBED 2-LAYER CONTINUOUS RUNNING SUTURES FOR LAPAROSCOPIC VAGINAL CUFF CLOSURE IS TECHNICALLY EASY AND REDUCES SURGICAL TIME. BARBED SUTURES ARE AS SAFE AND WELL-TOLERATED AS CONVENTIONAL SUTURES FOR VAGINAL CUFF CLOSURE DURING TLH. THE USE OF UNIDIRECTIONAL BARBED SUTURES IS A SAFE AND EFFICIENT ALTERNATIVE TO CONVENTIONAL SUTURES FOR LAPAROSCOPIC VAGINAL CUFF CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754293 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention