BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SLIM SUTURE CAPTURING DEVICE

    MDR report key: 6282472 · Received January 27, 2017

    Report

    Report Number
    6282472
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Date of Event
    January 9, 2017
    Report Date
    January 17, 2017
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE A SMALL PIECE OF THE TIP FROM A CAPIO SUTURE CAPTURING DEVICE, REF # 831826, EXP, DATE 2019-07-15, LOT #19482938 BROKE OFF AND LODGED ITSELF INTO THE RIGHT SACRAL SPINOUS LIGAMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66582 CAPIO SLIM SUTURE CAPTURING DEVICE HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC CORPORATION 19482938

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR