BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 22171629 · Received June 9, 2025

    Report

    Report Number
    2955842-2025-24314
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 13, 2025
    Report Date
    May 13, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO MECHANICAL INCONSISTENCY AT THE STERILE ADAPTER (SA) MOUNT INTERFACE ON THE PATIENT SIDE MANIPULATOR (PSM), WHICH PREVENTED PROPER SA RETENTION DURING INSTALLATION. THIS MISALIGNMENT LIKELY RESULTED IN THE DRAPE NOT SECURELY ATTACHING TO THE MANIPULATOR. SINCE NO FUNCTIONAL ANOMALIES WERE OBSERVED DURING INSTRUMENT CONTROL OR DRIVE TESTS, THE SECOND COMPLAINT COULD NOT BE SUBSTANTIATED.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE FOUND THE DRAPE WAS NOT HOLDING ONTO THE PATIENT SIDE MANIPULATOR (PSM). THE FSE REPLACED THE PSM TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE PSM TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM ISSUE OF DRAPE NOT HOLDING ONTO PSM AND REPRODUCE THE ISSUE DURING IN-HOUSE TESTING. FA WAS NOT ABLE TO CONFIRM NOR REPRODUCE THE ISSUE OF SURGEON COULD NOT TAKE CONTROL OF THE INSTRUMENTS. DURING VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM AND WHEN INSTALLING A STERILE ADAPTER (SA), THE SA WOULD POP OFF ON ONE SIDE. DESPITE THE RETENTION ISSUES, FA WAS ABLE TO INSTALL INSTRUMENTS AND DRIVE THE PSM WITH NO ISSUES. THE UNIT WAS THEN INSTALLED ONTO A PSC FIXTURE TEST PLATFORM (PFTP) WHERE IT PASSED ALL TESTING WITHIN SPECIFICATION. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS HAS CONCLUDED THAT THE SA MOUNT IS THE ROOT CAUSE OF THIS ISSUE. NOTE: THE UNIT PASSED THE OLED TEST, 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, SMOOTHNESS TEST, FRICTION TEST, FRICTION HIGH-SPEED SWEEP, AND BACKLASH TEST.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE PORT SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) THAT THE SURGEON SIDE CONSOLE (SSC) COULD NOT TAKE CONTROL. THE CUSTOMER POWER CYCLED THE SYSTEM TO RESOLVE THE ISSUE; HOWEVER, THE SURGEON STILL COULD NOT TAKE CONTROL OF THE INSTRUMENTS. TSE CONFIRMED ON SYSTEM LOGS NORMAL OPERATION AND INDICATED SURGEON AT THE CONSOLE VIEWER AND ARMS WERE CORRECTLY ASSIGNED WITH NO ERRORS. THE PROCEDURE WAS CONVERTED TO ANOTHER SYSTEM WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654561 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-40 N/A 00886874114605

    Patients

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