BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 10117380 · Received June 3, 2020

    Report

    Report Number
    2647580-2020-01737
    Event Type
    Injury
    Date Received
    June 3, 2020
    Date of Event
    February 29, 2020
    Report Date
    June 3, 2020
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: VAGINAL CUFF PERFORATION DURING ROBOTIC-ASSISTED MESH RECTO-SACROCOLPOPEXY SOURCE IJU CASE REPORTS, VOLUME 3, 2020(83-85). DATE OF PUBLICATION: 29 FEBRUARY 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF STUDY, THERE WAS A REPORTED COMPLICATION OF A (B)(6) FEMALE WHO UNDERWENT A ROBOTIC ASSISTED MESH RECTO-SACROCOLPOPEXY FOR PELVIC ORGAN PROLAPSE. INTRAOPERATIVELY, AN END-TO-END ANASTOMOTIC SIZER OF UNKNOWN BRAND WAS INSERTED INTO THE VAGINA TO FACILITATE DISSECTION OF THE VAGINAL CUFF. DURING MANEUVERING OF THE DEVICE'S SIZER, THE VAGINAL CUFF SPLIT OPEN AND THE DEVICE'S SIZER BECAME FULLY EXPOSED AT THE BOTTOM OF THE PELVIC CAVITY. FOLLOWING REPAIR OF THE COMPLICATION, THE PROCEDURE WAS CONTINUED ADDRESSING THE ENTEROCELE WITH SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581037 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention