BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 3054695 · Received April 6, 2013

    Report

    Report Number
    1219930-2013-00265
    Event Type
    Injury
    Date Received
    April 6, 2013
    Report Date
    March 7, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: ONE HUNDRED AND ONE WOMEN UNDERWENT LAPAROSCOPIC OR ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY FOR BENIGN OR MALIGNANT INDICATIONS. PATIENTS HAD A: (1) LAPAROSCOPIC HYSTERECTOMY (LH, N = 81), OR (2) ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY (RALH, N = 20). THE VAGINAL CUFF WERE CLOSED USING EITHER UNIDIRECTIONAL BARBED GLYCOLIC ACID - TRIMETHYLENE CARBONATE (0 QUILL SRS, N = 25), OR BIDIRECTIONAL BARBED POLYGLYCOLIC ACIDPOLYCAPROLACTONE (3-0 V-LOC 180, N = 76). INCIDENCE OF VAGINAL DEHISCENCE WAS (B)(4). THERE WERE NO STATISTICALLY DIFFERENCE BETWEEN LH AND RALH. ALTHOUGH THE INCIDENCE OF VAGINAL DEHISCENCE IS HIGHER IN THE GROUP USING V-LOC SUTURE ((B)(4)) THAN THE GROUP USING - QUILL SUTURE ((B)(4)), IT WAS NOT DIFFERENT STATISTICALLY (P = 0.44). THE TIMING OF THE DEHISCENCE OCCURRED ON DAY 2, 56, AND 70. INCREASED PHYSICAL ACTIVITY WAS FOUND TO BE THE INCIDENT EVENT LEADING TO VAGINAL DEHISCENCE. THE PRESENTING SYMPTOMS WERE VAGINAL BLEEDING. ALL THREE PATIENTS UNDERWENT SUCCESSFUL VAGINAL REPAIR WITH NO SUBSEQUENT DEHISCENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142422 UNKNOWN VLOC PRODUCT UNKNOWN VLOC GAM COVIDIEN, FORMERLY US SURGICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other