BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 16532919 · Received March 13, 2023

    Report

    Report Number
    2955842-2023-11252
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Date of Event
    February 14, 2023
    Report Date
    February 14, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERSONALITY MODULE VISION ACQUISITION (PMVA) UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED AND REPRODUCED THE CUSTOMER REPORTED COMPLAINT (ERROR 307). THE PMVA WAS TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE PART WAS NOT SEEN ON THE GEMINI LAPTOP APP. THE VIDEO BRANCH (VBR) BOARD HAS FAILED. UPON VISUAL INSPECTION, THE DIGITAL VIDEO INTERFACE (DVI) PORT ON THE VIDEO OUTPUT LEAF (VOL) WAS DAMAGED DUE TO WEAR AND TEAR. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 28-FEB-2023 AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION REGARDING THE REPORTED EVENT: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON, AND THE SYSTEM WORKED AS INTENDED UNTIL THE FAILURE OCCURRED AROUND HALFWAY THROUGH THE END OF THE SURGERY. AS REPORTED, THE SYSTEM POWERED ON WITHOUT ERRORS. THERE WAS NO RECOVERY FROM THE FAULT PRESENTED DURING THE PROCEDURE, AS A SOLUTION, THE SYSTEM CHANGE WAS PERFORMED, ANOTHER DAVINCI XI SYSTEM WAS USED ITO FINISH THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED FAULTS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE ISI FSE REPLACED THE PERSONALITY MODULE VISION ACQUISITION (PMVA) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA HAS BEEN ISSUED REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER-REPORTED ISSUE. ISI HAS NOT RECEIVED THE UNIT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO REPEATED FAULTS. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY - RADICAL WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER HAD ERROR 307 AND THERE WAS A LOSS OF VIDEO ON VISION SIDE CART (VSC). INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) GUIDED THE CUSTOMER TO RESTART THE SYSTEM AND CHECK IF ALL CABLES WERE CONNECTED DURING THE INITIALIZATION. DURING THE CALL, THE CUSTOMER REPORTED THAT THE LEDS FROM THE PERSONALITY MODULE VISION ACQUISITION (PMVA) WERE YELLOW. AFTER A HARD RESET, THE ERROR PERSISTED. THE MEDICAL TEAM OPTED TO CHANGE SYSTEMS. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976584 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-13 N/A 00886874110874

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES