BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SLIM

    MDR report key: 16815542 · Received April 26, 2023

    Report

    Report Number
    16815542
    Event Type
    Malfunction
    Date Received
    April 26, 2023
    Date of Event
    November 9, 2022
    Report Date
    December 23, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PWI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS IS THE NTH TIME WE ARE DOCUMENTING A REPORT OF THE CAPIO SLIM OPEN ACCESS SUTURE CAPTURING DEVICE. THE SAME CONCERN OF NOT ANCHORING, VERY UNSAFE AS IT IS A BLIND ACCESS APPROACH WHEN FIRED. TODAY, THE PATIENT BLED AND WE HAVE TO OPEN MORE SUPPLIES LIKE FLOSEAL, MORE SUTURES TO REINFORCE/REDO STITCHES THAT GAVE UP EVERY FAILED ATTEMPT FOR ANCHORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610129 CAPIO SLIM INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC, TRANSVAGINAL REPAIR PWI BOSTON SCIENTIFIC CORPORATION M0068318260 30254839

    Patients

    Seq Age Sex Outcome Treatment
    1 20075 DA Female