BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16313927 · Received February 7, 2023

    Report

    Report Number
    2955842-2023-10546
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 16, 2023
    Report Date
    January 16, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ACTIVATION HAS BEEN INTERRUPTED MESSAGE RECEIVED, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE ERBE TO RESOLVE THE ISSUE. AN 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. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE SYSTEM ENCOUNTERED AN ERROR U-02 ON THE ERBE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, 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 PROCEDURE CHANGE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. ON 07-MAR-2023, FAILURE ANALYSIS (FA) INVESTIGATIONS OF THE RETURNED UNIT CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE IESU GENERATOR WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED ISSUE (U-02 ERROR) WAS CONFIRMED AND REPRODUCED. THE UNIT WILL BE RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR REPAIR. THE COMPLAINT REGARDING THE CUSTOMER ENCOUNTERED A U-02 ERROR ON THE ERBE GENERATOR WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE IESU DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SYSTEM ENCOUNTERED AN ERROR U-02 ON THE INTEGRATED ELECTROSURGICAL UNIT (ERBE/IESU). THE CUSTOMER TRIED TO POWER CYCLE THE ERBE WITH NO CHANGE. THE CUSTOMER WAS UNABLE TO LOCATE THE BLUE ENERGY ACTIVATION CABLE TO CONNECT THE FORCE TRIAD TO THE DA VINCI SYSTEM. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED THE CUSTOMER TO POWER CYCLE THE ERBE AGAIN AND IF THE ISSUE PERSISTED, THE CUSTOMER WOULD NEED TO INSTALL THE FORCE TRIAD WITH THE ENERGY ACTIVATION CABLE OR REPLACE THE VISION TOWER. THERE WAS NO REPORTED INJURY. AN ISI TSE REVIEWED THE SYSTEM LOGS AND FOUND NO FAULTS REGARDING ERBE. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290681 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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