BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14467069 · Received May 22, 2022

    Report

    Report Number
    2955842-2022-11725
    Event Type
    Malfunction
    Date Received
    May 22, 2022
    Date of Event
    April 20, 2022
    Report Date
    April 20, 2022
    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
    NL
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS THEN TESTED AND VERIFIED AS READY FOR USE. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION, BUT THE FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED FOLLOWING COMPLETION OF THE EVALUATION. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE ELECTRO SURGICAL GENERATOR UNIT (ESU)] WAS NOT FUNCTIONING AS EXPECTED AFTER THE START OF THE PROCEDURE. THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A CONVERSION/ABORTION. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION IN PATIENT RACE, ETHNICITY, RELEVANT TESTS, RESULTS, AND PATIENT MEDICAL HISTORY WERE NOT PROVIDED. THE EXPIRATION DATE IS NOT APPLICABLE. IMPLANT DATE IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. PMA/510(K) NUMBER AND ADVERSE EVENT ARE NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    D02 - ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: D9, G3, G6, H2, H3, H6. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED AND REPRODUCED THE REPORTED FAILURE. THE IESU FAILED NORMAL MODE ON THE TEST SYSTEM WITH ERROR C-34.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER FACED ERROR C-34, M-11 C-30 ON THEIR ERBE GENERATOR. BEFORE CALLING IN FOR TECHNICAL SUPPORT, THE CUSTOMER RESTARTED THE ERBE WITHOUT SUCCESS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED THE ERRORS AND REQUESTED A SECOND RESTART WITH POWER REMOVAL FOR THE ERBE. THIS HAD NO EFFECT. THE TSE SUGGESTED TO USE AN EXTERNAL GENERATOR BUT THAT WAS NOT AVAILABLE. THE PROCEDURE CONTINUED AS PLANNED. THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS NOTED THAT THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM DID INITIALLY POWER ON WITHOUT ERRORS. IT WAS NOTED THAT THE BIPOLAR POWER FUNCTIONED, BUT THE MONOPOLAR DID NOT. THE ISSUE WAS NOT RESOLVED AND THE CUSTOMER DID NOT USE AN EXTERNAL GENERATOR TO PERFORM THE SURGERY. THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT.

    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
    552634 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-12 N/A

    Patients

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