BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18058442 · Received November 2, 2023

    Report

    Report Number
    2955842-2023-19746
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 13, 2023
    Report Date
    October 13, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED AND FOUND NO FAILURE. ERROR 23137 WAS CONFIRMED VIA LOGS BUT COULD NOT BE REPLICATED IN-HOUSE. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE AND PASSED. THE UNIT PASSED THE LISSAJOUS TEST, THE CURRENT SENSORS CHECK, THE SINE CYCLE, THE RANGE-OF-MOTION TEST AND RANGE OF MOTION. THERE WAS NO EVIDENCE OF FLUID INTRUSION.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND REPLACED USM 2 TO RESOLVE THE ISSUE. SYSTEM TESTED AND VERIFIED AS READY FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE THAT THE INSTRUMENTS ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2 MOVED IN THE OPPOSITE DIRECTION OF THE SURGEON'S COMMANDS. THE STAFF REMOVED THE ENDOSCOPE FROM USM 2, AND TURNED THE ENDOSCOPE COLLAR 180 DEGREES, WITH NO CHANGE. AN INTUITIVE TECH SUPPORT ENGINEER (TSE) REVIEWED THE ONSITE LOGS, WHICH SHOWED ERROR 23137 OCCURRED AGAINST USM 2 AXIS 4. THE STAFF REMOVED THE INSTRUMENTS AND REBOOTED THE SYSTEM. THEN THE USM STARTED WORKING NORMALLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL INC.(ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE ISSUE OCCURRED WITH THE SURGEON¿S HEAD INSIDE OF THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER, WHILE THE SURGEON WAS TRYING TO MANIPULATE INSTRUMENTS. THE FAILURE WAS NOT RELATED TO AN INABILITY TO MOVE THE INSTRUMENT. THE MOVEMENTS OF THE SURGEON DID SCALE APPROPRIATELY TO THE INSTRUMENT. THE INSTRUMENT MOVED IN THE COMPLETE OPPOSITE 180 DEGREE DIRECTION AS COMMANDED. THE TIMING OF INSTRUMENT MOVEMENT WAS APPROPRIATE. THERE WAS NO SHAKINESS AND/OR FRICTION EXPERIENCED/OBSERVED. THERE WAS NO INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE. THERE WERE NO EXTERNAL COLLISIONS. THE REPORTED ISSUE WAS PERSISTENT. THE SURGEON WAS TRYING TO SUTURE ALONG THE ABDOMINAL WALL AND THE USM WAS FORCING THE INSTRUMENT TO FACE TOWARD THE PATIENT'S BOWEL, WITHOUT ALLOWING THE SURGEON TO CHANGE DIRECTION. THE DRAPE ON THE USM WAS READJUSTED FIRST, BUT THIS DID NOT FIX THE ISSUE. THEN THE ENTIRE SYSTEM WAS SHUT DOWN AND RESTARTED IN ORDER TO RESOLVE THE ISSUE. THE DRAPE IS NOT AVAILABLE TO GET THE LOT NUMBER OR FOR RETURN. THERE WAS NO INJURY TO THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE WHILE DRAPING, AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY OBSERVED AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130807 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES