BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SLIM

    MDR report key: 6085642 · Received November 8, 2016

    Report

    Report Number
    6085642
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 21, 2016
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA . UNIQUE DEVICE IDENTIFIER (UDI): FOR TYPE OF DEVICE: HOLDER, NEEDLE, GASTROENTEROLOGIC.

    Description of Event or Problem · 1

    THE CAPIO DEVICE WOULD NOT HOLD THE SUTURE. A SECOND CAPIO WAS OPENED AND USED TO COMPLETE PROCEDURE. MANUFACTURER RESPONSE FOR CAPIO SUTURE CAPTURING DEVICE, CAPIO (PER SITE REPORTER). MANUFACTURER PROVIDED RGA# AND SHIPPING CONTAINER FOR PRODUCT RETURN EVALUATION.

    Description of Event or Problem · 1

    THE CAPIO DEVICE WOULD NOT HOLD THE SUTURE. A SECOND CAPIO WAS OPENED AND USED TO COMPLETE PROCEDURE. MANUFACTURER RESPONSE FOR CAPIO SUTURE CAPTURING DEVICE, CAPIO (PER SITE REPORTER). MANUFACTURER PROVIDED RGA# AND SHIPPING CONTAINER FOR PRODUCT RETURN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737455 CAPIO SLIM HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC CORPORATION M0068311250 18611631

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR