BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINPOINT ENDOSCOPIC FLUORESCENCE IMAGING SYSTEM

    MDR report key: 6758904 · Received August 1, 2017

    Report

    Report Number
    3012345110-2017-00004
    Event Type
    Malfunction
    Date Received
    August 1, 2017
    Date of Event
    July 20, 2017
    Report Date
    August 1, 2017
    Manufacturer
    NOVADAQ TECHNOLOGIES INC.
    Product Code
    GCJ
    PMA / PMN Number
    K161792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PINPOINT PROCEDURE, WHEN THE PINPOINT SYSTEM WAS TAKEN OFF STANDBY, THE LIGHT SOURCE WAS TURNED ON AND THE LAPAROSCOPE WAS WHITE-BALANCED (I.E. ALL WORKING NORMALLY). AT THAT POINT THERE WERE 2 "BEEPS" FROM WHAT SEEMED TO BE THE RECORDER OR VPI. THE DYE (ICG) WAS ADMINISTERED AND THE IMAGE ON THE SCREEN WORKED FINE. AFTER A FEW SECONDS THE SCREEN WENT BLACK AND THERE WAS THEN A "POP NOISE" THAT SOUNDED LIKE A FUSE SHORTING. THE CIRCULATOR NURSE UNPLUGGED THE TOWER AND OPENED UP THE BACK AND SMELLED SMOKE (DESCRIBED IT AS AN ELECTRIC FUSE SMELL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536570 PINPOINT ENDOSCOPIC FLUORESCENCE IMAGING SYSTEM ENDOSCOPE VIDEO IMAGING SYSTEM GCJ NOVADAQ TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1