BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINPOINT ENDOSCOPIC FLUORESCENCE IMAGING SYSTEM

    MDR report key: 6691056 · Received July 6, 2017

    Report

    Report Number
    3012345110-2017-00003
    Event Type
    Malfunction
    Date Received
    July 6, 2017
    Date of Event
    June 7, 2017
    Report Date
    July 6, 2017
    Manufacturer
    NOVADAQ TECHNOLOGIES INC.
    Product Code
    GCJ
    PMA / PMN Number
    K161792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A TLH PROCEDURE BEING CONDUCTED AT A HOSPITAL IN THE (B)(6) WITH SENTINEL NODE BIOPSY, THE VPI (COMPONENT OF THE PINPOINT SYSTEM) PRODUCED A 'POP' SOUND AND ALL POWER WAS LOST TO THE UNIT. THE SURGEON WAS MID OPERATION AND HAD JUST OPENED THE PERITONEUM ON THE PELVIC SIDE WALL TO BEGIN THE NODE DISSECTION. THIS WAS ABOUT 15 MINUTES INTO THE CASE (IN PINPOINT MODE). AFTER HEARING THE LOUD 'POP' SOUND THE IMAGE DISAPPEARED FROM THE SCREEN AND ALL POWER HAD BEEN LOST TO THE VPI. THE SYSTEM WAS THEN REBOOTED AND EVERY OTHER COMPONENT TURNED BACK ON EXCEPT THE VPI, THERE WAS NO ORANGE LIGHT ABOVE THE POWER BUTTON AND THE POWER DID NOT RESUME TO THE VPI. THE PATIENT WAS NOT BLEEDING AT THAT PRESENT TIME AND A NEW SYSTEM WAS BROUGHT IN TO CONTINUE THE OPERATION BUT WITHOUT THE SLN DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469448 PINPOINT ENDOSCOPIC FLUORESCENCE IMAGING SYSTEM ENDOSCOPE VIDEO IMAGING SYSTEM GCJ NOVADAQ TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1