BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN ACCESS CAPIO

    MDR report key: 19287566 · Received May 9, 2024

    Report

    Report Number
    MW5154715
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 7, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A CAPIO OPEN ACCESS DEVICE WAS USED AND FOUND TO BE DEFECTIVE DURING A SURGICAL PROCEDURE. THE REF NUMBER IS: M0068311250, EXP: 2026-11-05, GTIN: (B)(4). THE CAPIO DEVICE DID NOT FIRE THE NEEDLE. THE ITEM WAS REMOVED FROM THE FIELD AND SUBSTITUTED. THE SECOND DEVICE WORKED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450263 OPEN ACCESS CAPIO HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC CORPORATION 0068311250

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other