BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 16802442 · Received April 24, 2023

    Report

    Report Number
    2955842-2023-12152
    Event Type
    Injury
    Date Received
    April 24, 2023
    Date of Event
    March 28, 2023
    Report Date
    March 28, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING MONOPOLAR FIRING ISSUE DUE TO GENERATOR FAULT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE FSE CONFIRMED THAT THE ERBE FAULTED WITH M-02 ERROR DURING POWER ON SELF-TEST. THEREFORE, FSE REPLACED THE ERBE (PART NO: 951300-03, SERIAL NO: (B)(6)) IN ACCORDANCE WITH INTUITIVE SURGICAL, INC. (ISI) PROCEDURES. FAILURE ANALYSIS CONFIRMED AND REPLICATED THE REPORTED ISSUE ON THE ERBE. THE ROOT CAUSE OF THE REPORTED ISSUE WAS TRACED TO AN ELECTRICAL COMPONENT FAILURE ON THE UNIT. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO LAPAROSCOPIC SURGERY AFTER THE START OF THE PROCEDURE DUE TO MONOPOLAR NOT FUNCTIONING ON THE ELECTROSURGICAL UNIT (ESU). THE SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL INC (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED THE ISI TECHNICAL SERVICE ENGINEER (TSE) AND CONFERENCED IN THE CUSTOMER. THE CUSTOMER REPORTED M-02 ERRORS ON THEIR INTEGRATED ELECTROSURGICAL UNIT (IESU). PRIOR TO CALLING IN, THE CUSTOMER REBOOTED THE IESU AND REPLACED THE ENERGY CORD WITH NO CHANGE. THE TSE HAD THE CUSTOMER CHECK THE VISION SIDE CART (VSC) ENERGY PEDALS FOR OBSTRUCTION AND THEY STATED THERE WERE NONE. THE CUSTOMER PERFORMED HARD REBOOT ON THE IESU, AND IT FAULTED WITH NO EXTERNAL EQUIPMENT INSTALLED. THE CUSTOMER THEN REPORTED THAT THE OPERATING ROOM (OR) WAS ON THE LINE WITH TECHNICAL SUPPORT AND ENDED THE CALL. THE CUSTOMER CONTINUED TROUBLESHOOTING WITH OTHER TSE. THE CUSTOMER STATED THAT MONOPOLAR WAS NOT WORKING. THE TSE HAD THE CUSTOMER REBOOT THE ERBE AND SYSTEM AGAIN AND RESEAT ALL THE ERBE CABLES, HOWEVER THERE WAS NO CHANGE. THE CUSTOMER WAS THINKING ABOUT BRINGING IN ANOTHER VSC, BUT THE SURGEON HAD DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO PATIENT INJURY; HOWEVER, 2 TO 3 ADDITIONAL PORTS WERE PLACED ON THE PATIENT AFTER THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164191 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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