BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SLIM

    MDR report key: 6124275 · Received November 23, 2016

    Report

    Report Number
    6124275
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    August 30, 2016
    Report Date
    October 21, 2016
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE CAPIO SUTURE CAPTURING DEVICE WAS USED BY THE DOCTOR. THE NEEDLE (SUTURE) WAS NOT LOCKING AND PASSING THROUGH THE SUTURE DEVICE. PELVIC FLOOR MESH WAS NOT ABLE TO BE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776674 CAPIO SLIM HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC CORPORATION 19334999

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR NO