BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIDEO PROCESSOR/ILLUMINATOR (VPI)

    MDR report key: 9437753 · Received December 9, 2019

    Report

    Report Number
    3012345110-2019-00012
    Event Type
    Death
    Date Received
    December 9, 2019
    Date of Event
    November 7, 2019
    Report Date
    March 17, 2020
    Manufacturer
    NOVADAQ TECHNOLOGIES
    Product Code
    GCJ
    PMA / PMN Number
    K150956
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: INCORRECT SURGICAL DECISION MADE DUE TO INADEQUATE SPY-PHI IMAGING. PROBABLE ROOT CAUSE: ROOT CAUSE OF ALLEGED REPORTED ISSUE COULD NOT BE DETERMINED. NO FAULT FOUND ON THE VPI. FULL NIR FUNCTIONALITY WAS VERIFIED AND CONFIRMED. A KNOWN WORKING PINPOINT CAMERA WAS USED TO IMAGE A FLUORESCENT GREEN TARGET WHILE ELIMINATING EXTERNAL LIGHT FROM THE AREA. NO FLUORESCENCE WAS DETECTED OUTSIDE OF THE FLUORESCENT GREEN TARGET. THE ASSOCIATED SPY-PHI (HH18280587) DEVICE WAS ALSO TESTED USING A VIAL OF ICG ACTIVATED BY ALCOHOL AND NO FLUORESCENCE WAS DETECTED OUTSIDE OF THE ICG VIAL. A NUMBER OF MECHANICAL AND SOFTWARE ISSUES WERE IDENTIFIED FROM DEVICE LOGS AND INITIAL ANALYSIS OF PROVIDED PHOTOGRAPHIC EVIDENCE ALSO DEVELOPED SEVERAL POTENTIAL SCENARIOS INVOLVING VPI MALFUNCTION, MANUFACTURING ERRORS AND USER TAMPERING. HOWEVER, INVESTIGATION RULES OUT ANY POTENTIAL DEVICE-RELATED ISSUES AS A CAUSE OF REPORTED ISSUE. DURING ANALYSIS OF THE DEVICE LOGS, USAGE PATTERNS IDENTIFIED IN THE RELEVANT SESSIONS INDICATE THAT THE SPY PHI IMAGING SYSTEM WAS POTENTIALLY NOT BEING PROPERLY UTILIZED FOR ASSESSING PERFUSION IN THE SPECIFIC ANATOMY ASSOCIATED WITH THE SURGICAL PROCEDURE. HOWEVER, THE INFORMATION PIECED TOGETHER FROM THE LOGS ONLY PROVIDE A LIMITED VIEW OF HOW THE SPY PHI IMAGER WAS UTILIZED DURING EACH SPECIFIC SURGICAL CASE AND FURTHER DISCUSSION WITH THE ATTENDING SURGEON WILL BE REQUIRED TO CONFIRM THE SEQUENCE OF EVENTS LEADING TO THE FINAL MEDICAL DECISIONS MADE DURING EACH CASE. THE DEVICE WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS NOT REPRODUCED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE RE OCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TUMOR REMOVAL PROCEDURE RESULTED IN PATIENT DEATH. PLEASE NOTE, AT THIS TIME, IT CANNOT BE DETERMINED WHICH, IF ANY, OF THE REPORTED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO PATIENT OUTCOME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TUMOR REMOVAL PROCEDURE RESULTED IN PATIENT DEATH. PLEASE NOTE, AT THIS TIME, IT CANNOT BE DETERMINED WHICH, IF ANY, OF THE REPORTED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235414 VIDEO PROCESSOR/ILLUMINATOR (VPI) CONFOCAL OPTICAL IMAGING GCJ NOVADAQ TECHNOLOGIES PI18281611

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death