BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 15831258 · Received November 20, 2022

    Report

    Report Number
    2955842-2022-15399
    Event Type
    Malfunction
    Date Received
    November 20, 2022
    Date of Event
    October 20, 2022
    Report Date
    October 20, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INSTRUMENT DRIVE WAS NOT ACCEPTING INSTRUMENTS, 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 PSM WAS REPLACED TO CORRECT THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE PSM BACK FOR INVESTIGATION. THIS UNIT WAS RETURNED TO FAILURE ANALYSIS FOR THE INSTRUMENT DRIVE NOT ACCEPTING INSTRUMENTS. IN THE LOGS, FAILURE ANALYSIS WAS ABLE TO FIND (B)(4) ERRORS CONFIRMING AN ENGAGEMENT FAULT. ON THE SYSTEM, FAILURE ANALYSIS WAS UNABLE TO REPLICATE THE ERROR. THE PSM WAS TESTED WITH MULTIPLE STERILE ADAPTERS (SA) AND INSTRUMENTS WITHOUT SUCCESS. ON THE PSC FIXTURE TEST PLATFORM (PFTP), ALL TESTS PASSED INCLUDING SA PLUNGER CHECK, SA ENGAGEMENT CHECK, INSTRUMENT SENSOR CHECK, AND INSTRUMENT ENGAGEMENT SPLINE CHECK. AFTER TESTING, THE PRESENCE PINS WERE MANUALLY ACTUATED AND THERE WERE NO SIGNS OF RESISTANCE OR MECHANICAL FAULTS. THE UNIT PASSED SERVO TEST, PRELOAD MOTOR HEALTH CHECK, BRAKE SPEC TEST, BRAKE REPEATABILITY TEST, CLUTCH BUTTON CHECK, SA PLUNGER CHECK, SA ENGAGEMENT CHECK, PRELOAD SENSOR CHECK, INSTRUMENT SENSOR CHECK, INSTRUMENT ENGAGE SPLINE, SINE CYCLE, BELT SLIP CHECK, SMOOTHNESS TEST FRICTION TEST, FRICTION HIGH-SPEED SWEEP, AND BACKLASH TEST. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY THE TSE. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: (B)(4), A STERILE ADAPTER OR PLATE RETENTION PIN APPEARS TO BE STUCK. A REVIEW OF THE PROCEDURE LOG WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: SYSTEM (B)(4), EVENT DATE (B)(6) 2022, AND PROCEDURE HEAD AND NECK. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PSM WAS NOT ACCEPTING INSTRUMENTS AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY. 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 PROCEDURE CHANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT DRIVE HAD ENGAGEMENT ISSUES. THE SYSTEM WAS NO LONGER IN USE AT THE TIME OF THE CALL. THE CUSTOMER WAS NOT ABLE TO ACCESS THE PATIENT SIDE CART (PSC) TO TROUBLESHOOT AT THE TIME OF CALL. THE TECHNICAL SUPPORT ENGINEER (TSE) STATED THE LIVE LOGS SHOWED A PREVIOUS OCCURRENCE OF ERROR 30900 ON PATIENT SIDE MANIPULATOR (PSM) 2. THE CUSTOMER STATED THE STERILE ADAPTER KEPT POPPING OFF AND THE STAFF HAD A HARD TIME ENGAGING THE INSTRUMENTS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331036 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-45 N/A

    Patients

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