BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO NEEDLE

    MDR report key: 1171643 · Received September 10, 2008

    Report

    Report Number
    1171643
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    June 11, 2008
    Report Date
    September 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    SURGEON PERFORMING PROCEDURE WITH VERY SMALL NEEDLES. ONE NEEDLE WAS USED IN THE PATIENT AND CAME OFF THE INSTRUMENT. DR. STATES IT IS NOT RETRIEVABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO NEEDLE NEEDLE FHQ BOSTON SCIENTIFIC CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR