BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 24620885 · Received March 17, 2026

    Report

    Report Number
    2955842-2026-16210
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 20, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 NOT CONFIRMED. THE FSE WAS UNABLE TO REPLICATE REPORTED ISSUE, USING TEST INSTRUMENTS, ALL 4 ARMS WERE ENGAGED AND MOVED AS EXPECTED. THE FSE ATTEMPTED TO CREATE A SITUATION WHERE THE USER MAY HAVE REMOVED THEIR HANDS WHILE KEEPING THEIR HEAD IN PLACE, THE INSTRUMENTS REMOVED AT REST, THESE CONDITIONS WERE REPEATED 3-4 TIMES IN AN ATTEMPT TO CREATE UNWANTED MOVEMENT ON THE ARMS. ADJUSTED MONITOR ARM PER CUSTOMER REQUEST. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT IS A FEMALE, 38 YEARS OF AGE BORN ON 09-19-1987. SHE WEIGHED 195LBS, 30.25 BODY MASS INDEX, AND A HEIGHT OF 167.6 CM. NON-HISPANIC, WHITE WITH NO RELEVANT MEDICAL TESTS WERE PERFORMED. RELEVANT MEDICAL HISTORY: ANXIETY, BACK PAIN, ENDOMETRIOSIS, GALLSTONES, IBS (IRRITABLE BOWEL SYNDROME), NEUROPATHY, POLYCYSTIC OVARY SYNDROME, UTERINE POLYP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) STATED THAT THE SITE WAS USING ARM 4 TO RETRACT THE LIVER. THE SURGEON WAS NOT ACTIVELY CONTROLLING ARM 4 AND NOTED THAT IT SLOWLY DRIFTED. LOGS FOR THE PROCEDURE HAVE NOT YET POSTED. THE CLINICAL SALES REPRESENTATIVE (CSR) NOTED THAT IT DRIFTED A LITTLE AT A TIME. THERE WAS NO PATIENT INJURY, BUT HE IS REQUESTING FIELD SERVICE ENGINEER (FSE) TO CHECK ARM 4. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417544 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-33 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES