BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINPOINT ENDOSCOPIC FLUORESCENCE IMAGING SYSTEM

    MDR report key: 6993213 · Received November 1, 2017

    Report

    Report Number
    6993213
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    October 18, 2017
    Report Date
    October 27, 2017
    Manufacturer
    NOVADAQ TECHNOLOGIES INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PINPOINT BY NOVADAQ WAS IN USE ON THE SURGERY FIELD. THE SCOPE WAS ON AND WAS JUST USED FOR VISUALIZATION OF THE NECK. WHEN THE SURGEON FELT WARMTH, HE LOOKED AROUND AND NOTICED THE CORD WAS DETACHED FROM THE SCOPE. HE PULLED THE CORD TO LOOK AT IT AND HANDED IT TO THE SCRUB NURSE TO ATTEMPT AND RE-ATTACH THE CORD TO THE SCOPE. THE SURGERY CONTINUED WITHOUT ANY HARM. THE COUPLER WAS IN QUESTION ACCORDING TO THE OR NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773459 PINPOINT ENDOSCOPIC FLUORESCENCE IMAGING SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ NOVADAQ TECHNOLOGIES INC. PC9071

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR NONE THAT I AM AWARE OTHER THAN ANESTHESIA MACHINE