BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 4300011 · Received December 5, 2014

    Report

    Report Number
    1219930-2014-01125
    Event Type
    Injury
    Date Received
    December 5, 2014
    Report Date
    November 17, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TAPIA, J., GUILOFF, N., LAGOS, I., SOLARI, C., & PIZARRO, K. (2014). BARBED SUTURE VERSUS VIRYL FOR THE VAGINAL CUFF CLOSURE IN TOTAL LAPAROSCOPIC. GYNECOLOGICAL SURGERY. CONFERENCE: 23RD ANNUAL CONGRESS OF THE EUROPEAN SOCIETY OF GYNAECOLOGICAL ENDOSCOPY, ESGE 2014 BRUSSELS BELGIUM, 11(1 SUPPL. 1), 132-133. RETRIEVED NOVEMBER 17, 2014. OUR AIM WAS TO DO A RETROSPECTIVE ANALYSIS OF THE INTRA AND POSTOPERATIVE COMPLICATIONS WITH THE USE OF THREE DIFFERENT TECHNIQUES TO CLOSE THE VAGINA IN TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) IN 92 WOMEN. THIS WAS A SERIES OF TLH OVER A THREE YEAR PERIOD (JANUARY 2011 TO DECEMBER 2013). IT INCLUDED 92 CONSECUTIVE WOMEN REQUIRING HYSTERECTOMY. THREE SUTURE TECHNIQUES FOR THE CLOSURE OF VAGINAL CUFF WERE REVISED: BARBED SUTURE (VLOCK) PERFORMED BY LAPAROSCOPY, VICRYL PERFORMED BY LAPAROSCOPY AND VICRYL PERFORMED VAGINALLY. INTRAOPERATIVE , EARLY (0-7 DAYS) AND LATE POSTOPERATIVE (7-30 DAYS) COMPLICATIONS WERE REGISTERED. WE USED T-TEST TO ASSESS FOR DIFFERENCES BETWEEN GROUPS. THE AVERAGE AGE OF PATIENTS WAS 47,6 YEARS, RANGE 30 TO 78. FOR THE CLOSURE OF THE VAGINAL CUFF, BARBED SUTURE WAS USED IN 39,1% (36) OF THE HYSTERECTOMIES. 52,2% (48) WERE IN THE GROUP OF VICRYL SUTURE PERFORMED VAGINALLY, AND 3,3% (3) WERE VICRYL SUTURE PERFORMED BY LAPAROSCOPY. NO INTRAOPERATIVE COMPLICATIONS RELATED TO THE SUTURE OCCURRED. THE LATE POSTOPERATIVE COMPLICATIONS WERE: 1 VAGINAL CUFF DEHISCENCE WHICH REQUIRED RE-SUTURING ON THE 16TH POST OPERATORY DAY IN BARBED SUTURE GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788299 UNKNOWN VLOC PRODUCT UNKNOWN VLOC GAM COVIDIEN, FORMERLY US SURGICAL A DIVISON UNKNOWN-VLOC NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other