BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC ENDO STITCH RELOAD ABS

    MDR report key: 9281031 · Received November 5, 2019

    Report

    Report Number
    9612501-2019-02133
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    January 1, 2019
    Report Date
    November 5, 2019
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    OCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: SHORT-TERM OUTCOMES OF NONROBOTIC SINGLE-INCISION LAPAROSCOPIC SACROCOLPOPEXY: A SURGICAL TECHNIQUE SOURCE: JUAN LIU, MD, PHD, JADEN KOHN, MD, MPH, CHUNHUA WU, MD, ZHENKUN GUAN, MS, AND XIAOMING GUAN, MD, PHD, 2019, (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM OCTOBER 2016 TO NOVEMBER 2017, DURING SINGLE INCISION LAPAROSCOPIC SACROCOLPOPEXY (S-LSC) FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE, SUTURE WAS USED TO ANCHOR THE MESH TO THE VAGINAL FASCIA. OF THE 49 PATIENTS INCLUDED IN THE ANALYSIS, THREE PATIENTS DEVELOPED APICAL VAGINAL MESH EXPOSURE: OF THESE, ONE PATIENT WAS SYMPTOMATIC (BLOOD TINGED VAGINAL DISCHARGE 1 MONTH AFTER S-LSC) WHICH WAS RELIEVED BY TOPICAL APPLICATION OF ESTRIOL OINTMENT. THE OTHER TWO PATIENTS WERE ASYMPTOMATIC, BUT MESH EXPOSURE WAS NOTED ON A PHYSICAL EXAMINATION 3 MONTHS AFTER S-LSC AND WERE CONTINUING TO BE OBSERVED. ONE PATIENT HAD LUMBOSACRAL PAIN 1 MONTH AFTER S-LSC, WHICH WAS RELIEVED BY THE APPLICATION OF TRADITIONAL CHINESE MASSAGE FOR 1 WEEK. ADDITIONALLY, SIX PATIENTS COMPLAINED OF NEW ONSET OF STRESS URINARY INCONTINENCE: OF THESE, 1 CASE UNDERWENT A TENSION-FREE VAGINAL SUSPENSION, 2 CASES IMPROVED WITH PELVIC FLOOR TRAINING, AND 3 CASES WERE CONTINUING TO BE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075679 UNKNOWN VLOC ENDO STITCH RELOAD ABS ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW DAVIS & GECK CARIBE LTD UNKNOWN VLOC ENDO STITCH RELOAD ABS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention