BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMISITE

    MDR report key: 20354554 · Received October 2, 2024

    Report

    Report Number
    3004962788-2024-00111
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 19, 2024
    Report Date
    December 19, 2024
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    JAK
    UDI-DI
    10884521723818
    PMA / PMN Number
    K191394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE REPORTED ISSUES WERE CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO A COMPONENT FAILURE. INTERNAL PROCESS IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CATHETER PERFORM NORMAL AT FIRST WHEN NAVIGATING AND REACHED THE TARGET THEN PROCEEDED TO USE ULTRASOUND TO CONFIRM THE LOCATION OF THE CATHETER. AFTER THAT THE PHYSICIAN WOULD LIKE TO ADJUST THE CATHETER FOR BETTER ALIGNMENT HENCE REINSERTING THE LOCATABLE GUIDE (LG) TO EXTENDED WORKING CHANNEL (EWC). ONCE LG WAS REINSERTED TO EWC, THE SYSTEM COULD NOT SENSE THE LG SENSOR THAT THE CONSOLE SHOWING THE LOCATION OF THE EWC SENSOR ONLY AND THE SIGNAL START LAGGING AND THE DISPLAY OF THE LOCATION OF THE CATHETER IS NOT SMOOTH.  TROUBLESHOOTING WAS PERFORMED BY DISCONNECTING ALL CABLES OF LG AND EWC, ALSO WITHDRAWING THE LG FROM EWC AND REINSERT. ALSO, THE CABLE CONNECTION TO THE MONITOR WAS CHECKED, AND FURTHER CONFIRM THAT NO POSSIBLE INTERFERENCE IN OUR SIGHT WHICH C-ARM IS IN RECOMMENDED DISTANCE, YET THE SITUATION DID NOT IMPROVE AND EVENTUALLY THE ERROR POPPED OUT INDICATING THAT "OUT OF SENSING VOLUME" EVEN THE PATIENT WHICH IS UNDER MAC AND LOCATION BOARD REMAIN CONSTANT. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635888 ILLUMISITE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK COVIDIEN LP - SUPERDIMENSION INC ILS-1800-KT 528178 10884521723818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown