BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15826192 · Received November 18, 2022

    Report

    Report Number
    2955842-2022-15360
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    October 19, 2022
    Report Date
    February 13, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MASTER TOOL MANIPULATOR (MTM) GIMBAL ASSEMBLY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATIONS OF THE RETURNED ASSEMBLY CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE FAILURE ANALYSIS INVESTIGATIONS REPRODUCED THE REPORTED FAILURE (ERROR 23008 ALONG AXIS 5/PLATFORM) DURING THE SINE CYCLE. THE COMPLAINT REGARDING THE CUSTOMER ENCOUNTERED REPEATED COVERABLE ERROR 23008 WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATED THAT THE MTM ASSEMBLY DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO COMPONENT FAILURE.

    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 WAS ABLE TO REPRODUCE THE REPORTED PROBLEM. THE FSE NOTED THAT THE ISSUE COULD NOT BE RESOLVED WITH A SYSTEM REBOOT. THE FSE REVIEWED THE SYSTEM LOGS AND IDENTIFIED ERROR 23008 POINTING TO AXIS 5 OF THE RIGHT MASTER TOOL MANIPULATOR (MTM). THE FSE REPLACED THE RIGHT MTM GIMBAL ASSEMBLY TO RESOLVE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE MTM GIMBAL ASSEMBLY FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED FOLLOWING COMPLETION OF THE EVALUATION. A LOG REVIEW CONFIRMED THE SEGMENTAL PANCREATECTOMY PROCEDURE ON (B)(6) 2022 ON SYSTEM (B)(4). NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE (FIRST PORT INCISION) CONTRIBUTED TO THE PROCEDURE BEING CONVERTED TO LAPAROSCOPIC. ALTHOUGH NO PATIENT HARM WAS REPORTED, IF THE ALLEGED MALFUNCTION WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 0

    REFER FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SEGMENTAL PANCREATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO REPORT THAT THEY ENCOUNTERED REPEATED COVERABLE ERROR 23008. THE SURGEON COULD NOT MANIPULATE THE RIGHT MASTER TOOL MANIPULATOR (MTM) AT THE TIME OF THE EVENT. SYSTEM FUNCTIONALITY WAS REPORTEDLY CHECKED PRIOR TO USE, AND NO ISSUES/ERRORS WERE NOTED. THE SITE PRESSED THE RECOVER BUTTON AND POWER CYCLED THE SYSTEM, BUT THE ERROR/ISSUE COULD NOT BE RESOLVED. THE SURGEON THEN ELECTED TO CONVERT TO TRADITIONAL LAPAROSCOPIC SURGERY. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION REGARDING THE REPORTED EVENT: IT WAS CONFIRMED THAT THERE WAS NO PATIENT HARM, INJURY OR ADVERSE OUTCOME DUE TO THE PROCEDURE CONVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238791 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-26 N/A

    Patients

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