BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16001625 · Received December 18, 2022

    Report

    Report Number
    2955842-2022-16014
    Event Type
    Malfunction
    Date Received
    December 18, 2022
    Date of Event
    November 18, 2022
    Report Date
    November 18, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ORIENTATION ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL, INC (ISI)TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. THE CUSTOMER PERFORMED A HARD POWER CYCLE TO RESOLVE THE ISSUE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE ENDOSCOPE ORIENTATION WAS INCORRECT, AND THE MOVEMENT OF INSTRUMENTS WERE NON-INTUITIVE AS A RESULT. POOR CAMERA CONTROL COULD RESULT IN UNINTUITIVE MOTION AND SUBSEQUENT TISSUE DAMAGE. THE ISSUE WAS RESOLVE THROUGH A SYSTEM RESTART, BUT THE ENDOSCOPE DID NOT NEED TO BE RESEATED, INDICATING THAT IT WAS INSTALLED CORRECTLY. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, SURGEON WAS EXPERIENCING NON INTUITIVE MOVEMENT OF INSTRUMENTS AND THE IMAGE HAD INCORRECT ORIENTATION. A TECHNICAL SERVICE ENGINEER (TSE) ASKED THE CALLER TO CONFIRM IF ENDOSCOPE WAS PHYSICALLY TURNING WHEN SWITCHED BETWEEN UP AND DOWN WITH THE CONTROLS. THE CALL GOT DISCONNECTED DUE TO BAD CONNECTION SO THE RESPONSE WAS UNKNOWN. THE CUSTOMER CALLED BACK FROM ANOTHER LINE AFTER A SHORT WHILE AND REPORTED THAT THEY HAD PERFORMED A HARD POWER CYCLE, AND EVERYTHING WORKED AS NORMAL AFTER THAT. THEY PLANNED TO CALL BACK IF THE ISSUE HAPPENED AGAIN. ON (B)(6)2022, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SR TECHNICAL SUPPORT ENGINEER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: BECAUSE THE IMAGE WAS INVERTED, THE MOVEMENT OF THE INSTRUMENT APPEARED INVERTED. THEREFORE, THE "NON INTUITIVE MOTION" OF THE INSTRUMENTS WAS DUE TO THE IMAGE ORIENTATION ISSUE, AND MOST LIKELY USER INDUCED. ON (B)(6)2022, ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS RESOLVED AFTER A HARD-CYCLE POWER RESTART. THE CAMERA DID NOT HAVE TO BE RESEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152421 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

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