BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL GENERIC PRODUCT CODE

    MDR report key: 7882074 · Received September 17, 2018

    Report

    Report Number
    3005075853-2018-12805
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Report Date
    September 3, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    TITLE: BARBED VERSUS CONVENTIONAL 2-LAYER CONTINUOUS RUNNING SUTURES FOR LAPAROSCOPIC VAGINAL CUFF CLOSURE AUTHORS: JIN HWI KIM, MD, PHDA, SEUNG WON BYUN, MDA, JAE YEON SONG, MD, PHDA, YEON HEE KIM, MD, PHDA, HEE JOONG LEE, MD, PHDA, TAE CHUL PARK, MD, PHDA, KEUN HO LEE, MD, PHDB, SOO YOUNG HUR, MD, PHDB, JONG SUP PARK, MD, PHDB, SUNG JONG LEE, MD, PHDC 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
    720939 ENSEAL GENERIC PRODUCT CODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1