BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 20055741 · Received August 23, 2024

    Report

    Report Number
    2955842-2024-18257
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 24, 2024
    Report Date
    July 25, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874122228
    PMA / PMN Number
    K212101
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE CAMERA INSTRUMENT WAS ANALYZED, AND THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE CAMERA WAS FOUND TO HAVE MULTIPLE 48221, 48216, 48225, 48229, 45310, 45314, 48406 ERRORS DURING LOG REVIEW BUT WAS NOT REPLICATED DURING IN-HOUSE TESTING. THE CAMERA PASSED ALL FUNCTIONAL TEST DURING IN-HOUSE TESTING. THE CAMERA PASSED ENGAGEMENT AND RECOGNITION ON MULTIPLE ATTEMPTS ON IN-HOUSE SYSTEM. THE QAP (QUALITY ASSURANCE PROCEDURE) WAS PERFORMED AND PASSED DURING THE FOCUS TEST AND WAS ABLE TO RECOGNIZE ALL DIFFERENT TARGETS/IMAGES WITH NO QUALITY ISSUE. THERE WAS NO GHOSTING OBSERVED WHEN SWITCHING FROM DIFFERENT TARGETS. BOTH THE RIGHT EYE AND LEFT EYE PASSED FOCUS TEST AND APPEARED TO HAVE READABLE GOOD IMAGE QUALITY. THE BUTTON FUNCTION TO ROTATE THE CAMERA HAD NO ISSUE. PERFORMED THE FIREFLY TEST WITH NO ISSUE. A REVIEW OF THE LOGS SHOWED THE FOLLOWING MULTIPLE ERRORS: 48406 WATCHDOG ILLUMINATOR TIMEOUT 48216 CAMERA TEMPERATURE SENSOR FAILURE (B)(6) CAMERA COMMUNICATION ERROR 48225 CAMERA POWER FAILURE 48229 -CAMERA POWER WARNING 45310 LOSS OF IMAGE BOTH EYES (LOST SURGEON VIDEO) 45314 VIDEO FROZEN NOTE: THE CAMERA FAILED ON FIRST EDT (ENDOSCOPE DIAGNOSTICS TEST) TEST, FAILED TIP ARTICULATION BUT PASSED ON SECOND EDT (ENDOSCOPE DIAGNOSTICS TEST) TEST. ADDITIONAL OBSERVATIONS NOT RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE CAMERA WAS FOUND TO HAVE MARKINGS ON THE HOUSING. THE MARKINGS WERE FOUND ON ONE SIDE OF THE CAMERA COVER HOUSING. THE CABLE CONNECTOR WAS FOUND TO HAVE DAMAGE ON THE CABLE LIGHT GUIDE FERRULE. HEAT DAMAGE WAS FOUND ON FERRULE. THE INSTRUMENT WAS FOUND TO HAVE SOME DRIED RESIDUE AROUND THE CLAMPING PULLEY CABLE GROOVES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CAMERA SHUT OFF DURING THE CASE AND THE IMAGE WENT COMPLETELY BLACK, ERROR MESSAGE "CHECK CONNECTION" WAS RECEIVED. THE CUSTOMER WAS NOT ABLE TO RE-START IT OR GET IT TO WORK. THE CUSTOMER HAD TO BORROW ONE FROM ANOTHER HOSPITAL, WHICH WAS ABOUT 1 AND HALF HOUR AWAY AND DELAYED THE CASE. THERE WAS NO PATIENT INJURY OR IMPACT. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618645 ENDOWRIST SP CAMERA, 0° NAY INTUITIVE SURGICAL, INC 430077-02 N/A 00886874122228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other DA VINCI INSTRUMENTS AND ACCESSORIES