BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18263649 · Received December 4, 2023

    Report

    Report Number
    2955842-2023-20900
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 9, 2023
    Report Date
    November 9, 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
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS THE INSTRUMENT ARM DRAPE NOT BEING PROPERLY MOUNTED AND THEREFORE NOT ENGAGING WITH THE INSTRUMENT FULLY CAUSING THE ISSUE. WITH GUIDANCE WE REMOVED THE PLASTIC PIECES THAT ATTACH TO THE ROBOTIC ARM AND REHOUSED THEM WHICH SOLVED THE ISSUE. A SPECIFIC ARM OF THE ROBOT HAD THE ISSUE. THE ISSUE WAS PRESENT WITH MULTIPLE INSTRUMENTS BUT ONLY ON THIS ARM. WHEN USED IN OTHER ARMS THEY WORKED NORMALLY. ISSUE OCCURRED WITH THE SURGEON¿S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER AND WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON CONSOLE. INSTRUMENT WAS NOT STATIC. THE MOVEMENTS OF THE SURGEON SCALED APPROPRIATELY TO THE INSTRUMENT (E.G., DISTANCE INTENDED MATCHED DISTANCE INSTRUMENT MOVED). THE INSTRUMENT MOVEMENT WAS INVERTED. WHEN SURGEON MOVED UP IT MOVED DOWN, WHEN THEY MOVED LEFT IT MOVED RIGHT ETC. BUT IT MOVED 1:1 AS NORMAL. THE TIMING OF INSTRUMENT MOVEMENT WAS APPROPRIATE. THERE WAS NO SHAKINESS AND/OR FRICTION EXPERIENCED/OBSERVED. THERE WERE NO EXTERNAL COLLISIONS. ISSUE WAS PERSISTENT UNTIL SOLVED. START OF THE CASE AFTER INITIAL INSTRUMENT PLACEMENT. ISSUE NOTICED WHEN SURGEON FIRST WENT TO THE CONSOLE TO BEGIN ROBOTIC ASPECT OF SURGERY. SITE NEVER EXPERIENCED ISSUE BEFORE. ADVISED TO CONTACT HELP CENTER. THEY ADVISED REMOVAL OF INSTRUMENT AND UNSEATING DRAPE FROM ARM AND REAPPLYING WHICH DID SOLVE ISSUE SUCCESSFULLY. NO FURTHER ISSUES THEREAFTER.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE SITE RESEATED THE STERILE ADAPTER (SA) TO RESOLVE THE REPORTED ISSUE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. A RETURN MATERIAL AUTHORIZATION WAS NOT ISSUED FOR RETURN AS THE ISSUE WAS RESOLVED WITH PHONE SUPPORT. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE MOVEMENT OF THE INSTRUMENT ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1 WAS INVERTED. BEFORE CALLING INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE), THE CUSTOMER ALREADY TRIED THE SAME INSTRUMENT ON ANOTHER USM, AND IT FUNCTIONED AS EXPECTED THERE. THE TSE CHECKED THE LOGS AND FOUND NO RELATED ERRORS. THE TSE ADVISED TO RESEAT THE STERILE ADAPTER (SA) ON USM 1, AND THIS SOLVED THE ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063955 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-49 N/A 00886874110720

    Patients

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