BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 18380388 · Received December 21, 2023

    Report

    Report Number
    2955842-2023-21610
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 28, 2023
    Report Date
    November 28, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115374
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTED WAS PRESENT ONSITE THE 28-NOV-2023 MORNING AND NO ERROR MESSAGE ON THE SYSTEM OCCURRED. THE SYSTEM WAS CHECKED BEFORE. THE SYSTEM POWERED ON WITHOUT ERRORS AND NO INJURY TO THE PATIENT. THE SURGEON CONVERTED DUE TO THE ABNORMAL 3D IMAGE. THE INITIAL PORTS WERE USED. THE PATIENT WAS ABLE TO TOLERATE THE CONVERSION.

    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. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE PERSONALITY MODULE SURGEON CONSOLE (PMSC), VIDEO PROCESSOR (VP) AND ENDOSCOPE CONTROLLER (EC) TO RESOLVE THE 3D VISION ISSUES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE COMPONENTS; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION.

    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 PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CALLED THE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE 3D MERGE WAS STILL PRESENT AT THE CONSOLE EVEN AFTER DISCONNECTING ALL EXTERNAL MONITORS, REPLACING ENDOSCOPE AND POWERING CYCLE THE SYSTEM. THE SURGEON REQUESTED FOR A SOLUTION. THE TSE COULD NOT FIND ANYTHING RELEVANT IN THE LIVE SYSTEM LOGS. THE TSE ASKED THE CALLER TO CHECK IF THE LEFT AND RIGHT EYE WAS FINE AT THE VISION SIDE CART (VSC). THE 3D VIEW SEEMED TO BE NOT WELL ALIGNED AT THE SURGEON SIDE CONSOLE (SSC). THE SURGEON WAS CONVERTING TO LAPAROSCOPIC SURGERY. THE ISSUE HAS RETURNED CAUSING THE SYSTEM TO NOT WORK PROPERLY. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY AND COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152388 DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380723-10 N/A 00886874115374

    Patients

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