BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 16565903 · Received March 17, 2023

    Report

    Report Number
    2955842-2023-11353
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 21, 2023
    Report Date
    February 21, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110690
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT ERROR 23017 OCCURRED ON PATIENT SIDE MANIPULATOR (PSM) 3, AN INVESTIGATION IS IN PROGRESS 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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE NOTED THAT ERROR 223017 OCCURRED ON PSM 3 SEVERAL TIMES. THE FSE REPLACED THE PSM TO RESOLVE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS REQUESTED THE PSM FOR EVALUATION, BUT THE PRODUCT HAS NOT YET BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. THE COMPLAINT REGARDING ERROR 23017 OCCURRED WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: A PSM WAS DISABLED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY USING 3 ARMS. 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. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND 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 A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PATIENT SIDE MANIPULATOR (PSM) WAS ANALYZED AND FOUND TO HAVE NO ISSUE. FAILURE ANALYSIS INVESTIGATIONS COULD NOT REPRODUCE THE REPORTED FAILURE (ERROR 23017 ALONG PITCH/AXIS 2). HOWEVER, THE ERROR COULD BE CONFIRMED AS HAVING OCCURRED VIA THE FIELD ERROR LOGS. THE PSM WAS INSTALLED ONTO A SYSTEM AND POWERED UP. THE SINE CYCLE AND TEST DRIVE WERE PERFORMED WITHOUT ANY ISSUES. THE UNIT ALSO PASSED ALL TESTS THAT WERE PERFORMED VIA MATLAB. THERE WAS NO TROUBLE FOUND WITH THIS PSM. THE ROOT CAUSE IS NOT DETERMINABLE/APPLICABLE. THE COMPLAINT REGARDING ERROR 23017 OCCURRED WAS NOT CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO REPORT THAT ERROR 23017 OCCURRED ON PATIENT SIDE MANIPULATOR (PSM) 3. THE CUSTOMER PRESSED THE ¿RECOVER¿ SELECTION TO RECOVER FROM THE ERROR. SYSTEM FUNCTIONALITY WAS REPORTEDLY CHECKED PRIOR TO USE, AND NO ISSUES/ERRORS WERE NOTED. THE SITE CONTINUED WITH THE PROCEDURE AS PLANNED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SITE DISABLED PSM 3 DURING THE PROCEDURE. THE SITE CONTINUED AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH THE REMAINING ARMS.

    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
    559192 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-15 N/A 00886874110690

    Patients

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