BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIWIRE NITINOL WIRE GUIDE

    MDR report key: 5737948 · Received June 21, 2016

    Report

    Report Number
    5737948
    Event Type
    Malfunction
    Date Received
    June 21, 2016
    Date of Event
    January 6, 2016
    Report Date
    May 25, 2016
    Manufacturer
    COOK, INC.
    Product Code
    OCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA. DEVICE MODEL #: FOR TYPE OF DEVICE: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY UNIQUE DEVICE IDENTIFIER (UDI): FOR TYPE OF DEVICE: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY.

    Description of Event or Problem · 1

    DOCTOR INSERTED THE GUIDEWIRE IN THE CYSTOSCOPE, FELT RESISTANCE IN ADVANCING THE GUIDEWIRE, HE PULLED THE GUIDEWIRE OUT OF THE SCOPE AND FOUND THAT THE GUIDEWIRE COATING APPEARED TO BE FLAKING OFF.

    Description of Event or Problem · 1

    DOCTOR INSERTED THE GUIDEWIRE IN THE CYSTOSCOPE, FELT RESISTANCE IN ADVANCING THE GUIDEWIRE, HE PULLED THE GUIDEWIRE OUT OF THE SCOPE AND FOUND THAT THE GUIDEWIRE COATING APPEARED TO BE FLAKING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393608 HIWIRE NITINOL WIRE GUIDE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY COOK, INC. HWS-035150 10607841

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR