BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 20829031 · Received December 3, 2024

    Report

    Report Number
    2955842-2024-22659
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 7, 2024
    Report Date
    November 7, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    IZI
    UDI-DI
    00886874122228
    PMA / PMN Number
    K212101
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PRODUCT WAS ANALYZED AND WAS FOUND TO HAVE THE SIGN OF FLUID INGRESS WAS NOTICED ON THE PROXIMAL SIDE. MOSTLY THE FLUID WAS ON THE PERIMETER RING WITH FEW SPOTS ON THE FIBER OPTICAL APERTURE AS CIRCLED IN THE ATTACHED IMAGE. THIS IS RESULT OF THE LEAKAGE BETWEEN THE INNER FERRULE AND THE OUTER FERRULE WHICH THE DESIGN FIX IS IN PROGRESS. THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE ENDOSCOPE FIREFLY BE RETURNED FOR FAILURE ANALYSIS TESTING. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PRODUCT WAS ANALYZED AND WAS FOUND TO HAVE MULTIPLE 48221, 48406, 48216, 48221, 4822 AND 48229 ERRORS DURING LOG REVIEW WAS CONFIRMED FROM THE SCOPE ERROR FINDER BUT WAS NOT REPLICATED DURING IN-HOUSE TESTING. THE CAMERA PASSED THE ENGAGEMENT AND RECOGNITION ON MULTIPLE ATTEMPTS ON IN-HOUSE SYSTEM. THE QAP (QUALITY ASSURANCE PROCEDURE) WAS PERFORMED AND PASSED CALIBRATION AND WAS ABLE TO RECOGNIZE ALL DIFFERENT TARGETS/IMAGES WITH NO ISSUE ON DIFFERENT DISTANCES. THERE WAS NO GHOSTING OBSERVED WHEN SWITCHING FROM DIFFERENT TARGETS. BOTH THE RIGHT EYE AND LEFT EYE APPEARED TO HAVE READABLE GOOD IMAGE QUALITY. THE BUTTON FUNCTION TO ROTATE THE CAMERA HAD NO ISSUE. PERFORMED FIREFLY TEST WITH NO ISSUE ON THE IN-HOUSE SYSTEM. THE CAMERA PASSED AIR LEAK TEST AND PASSED THE FIRST EDT TEST. THE ROOT CAUSE IS NOT DETERMINABLE. A REVIEW OF THE LOGS SHOWED THE FOLLOWING ERRORS: 48406 WATCHDOG ILLUMINATOR TIMEOUT, 48216 CAMERA TEMPERATURE SENSOR FAILURE, 48221 CAMERA COMMUNICATION ERROR, 48225 CAMERA POWER FAILURE, 48229 -CAMERA POWER WARNING. ADDITIONAL OBSERVATIONS NOT RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE CAMERA FAILED THE SECOND EDT TEST DUE TO THE IMAGES BEING GRAINY OR NOT SMOOTH DURING THE TEST. ILLUMINATION AND CAPTURE IMAGE, TIP ARTICULATION. THE CAMERA BUTTON PACK WAS FOUND TO HAVE MECHANICAL INDENTATION. THE ILLUMINATOR BUTTON AND BUTTON INVERT HAD INDENTATIONS/DAMAGE ON THE BUTTON¿S EDGES. THE ROOT CAUSE IS TYPICALLY ATTRIBUTED TO USER. THE CABLE CONNECTOR WAS FOUND TO HAVE DAMAGE ON THE CABLE LIGHT GUIDE FERRULE. HEAT DAMAGE WAS FOUND ON FERRULE. THE ROOT CAUSE OF CABLE CONNECTOR ¿ FERRULE DAMAGE IS TYPICALLY ATTRIBUTED TO THE USER, SUCH A IMPROPER REPROCESSING. THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY RADICAL EXTRAPERITONEAL WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THAT THE FIREFLY WAS WAS NO RECOGNIZING. THE CUSTOMER WAS SENDING THE FIREFLY FOR RETURN MATERIAL AUTHORIZATION. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROBLEM WAS IDENTIFIED DURING THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS ANY FRAGMENT FELL INTO THE PATIENT AND IF THE PATIENT WAS INJURED. THE PROBLEM DELAYED THE OPERATION BUT THE MINUTES WERE UNKNOWN.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296992 ENDOWRIST SP CAMERA, 0° IZI INTUITIVE SURGICAL, INC 430077-05 N/A 00886874122228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES