BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 16286174 · Received February 2, 2023

    Report

    Report Number
    2955842-2023-10478
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    January 8, 2023
    Report Date
    January 8, 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
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A NOISY IMAGE ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WILL BE DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE DOUBLE CAMERA CONTROLLER (DOCO) DUE TO THE DEGRADED IMAGE QUALITY ON BOTH EYES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE DOCO 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 INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER ABORTED AFTER THE START OF THE PROCEDURE DUE TO AN IMAGE ISSUE ON THE DOUBLE CAMERA CONTROLLER (DOCO). 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DOUBLE CAMERA CONTROLLER (DOCO) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION COULD NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT ¿NOISY IMAGE, AND PART OF THE IMAGE WAS MISSING¿. UPON VISUAL INSPECTION, THE DOCO UNIT WAS RETURNED IN GOOD CONDITION. THE DOCO UNIT WAS INSTALLED INTO THE TEST SYSTEM AND WHITE BALANCE, CALIBRATION WAS PERFORMED, 10 MINUTES SINE CYCLE, 10 POWER CYCLES WERE RUN & LEFT IDLE FOR AN HOUR. THE SYSTEM CAME UP WITH NO ERRORS AND GOOD VIDEO ON BOTH EYES AND NO ISSUES NOTED. THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE COMPLAINT REGARDING IMAGE ISSUE WAS NOT CONFIRMED BASED ON THE FAILURE ANALYSIS, WHICH INDICATED THAT THE DEVICE DID NOT CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A NOISY IMAGE AND AFTER CALIBRATION, PARTS OF THE IMAGE WAS MISSING. THE CALLER STATED THAT THEY WERE NOT ABLE TO TEST WITH THE SECOND CAMERA. ISSUE FOUND DURING CASE SETUP. THE PROCEDURE WAS CANCELED. ON (B)(6)2023, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE QUALITY ASSURANCE SPECIALIST AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROBLEM WAS NOTICED AFTER ANESTHESIA. THE PATIENT WAS ANESTHETIZED. ON (B)(6)2023, FURTHER INFORMATION WAS OBTAINED FROM THE QUALITY ASSURANCE SPECIALIST: IT WAS A PROSTATECTOMY PROCEDURE, AND THE PATIENT WAS UNDER ANESTHETIZED FOR ONE HOUR. THERE WERE NO POST-OPERATIVE COMPLICATIONS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936336 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-11 N/A 00886874110874

    Patients

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