BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15831249 · Received November 19, 2022

    Report

    Report Number
    2955842-2022-15397
    Event Type
    Malfunction
    Date Received
    November 19, 2022
    Date of Event
    October 20, 2022
    Report Date
    October 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
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE REPORTED COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION. THE FSE FOUND THE ERBE TO BE WORKING PROPERLY. AS A PRECAUTION, AND AT THE REQUEST OF THE SITE, THE FSE REPLACED THE ERBE. THE SYSTEM PASSED ALL REQUIRED TESTS. THE SYSTEM IS WORKING PROPERLY. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS, BUT THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE UNIT ENERGIZED AND CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS. THE UNIT WILL BE RESTOCKED FOR FUTURE USE. A LOG REVIEW CONFIRMED THE PROCEDURE DATE OF (B)(6) 2022 ON SYSTEM (B)(4). NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO A LAPAROSCOPIC PROCEDURE AFTER THE START OF THE MONOPOLAR ENERGY NOT WORKING. 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 A PROCEDURE CHANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE THAT THERE WAS NO MONOPOLAR ENERGY OUTPUT ON THE PERMANENT CAUTERY HOOK. PRIOR TO CALLING, THE CALLER REPLACED THE INSTRUMENT, AND GREEN MONOPOLAR ENERGY ACTIVATION CABLE, WITH NO CHANGE. THERE WERE NO RELATED ERRORS IN THE LOGS. THE INTUITIVE TECH SUPPORT ENGINEER COULD OBSERVE PERMANENT CAUTERY HOOK INSTRUMENT OUTPUT AT 3 AND 3 ON UNIVERSAL SURGICAL MANIPULATOR 4 (USM4). THE TSE COULD OBSERVE THE ERBE AUDIO TONES WHEN THE SURGEON CALLED FOR ENERGY. THE CALLER CONFIRMED THAT THE BIPOLAR ENERGY IN USM2 WAS WORKING WITHOUT ISSUE. THE TSE WALKED THE CALLER THROUGH MOVING THE MONOPOLAR OUTPUT FROM THE TOP TO THE BOTTOM OUTPUT ON THE ERBE, WITH NO CHANGE. THE TSE WALKED THE CALLER THROUGH A POWER CYCLE OF THE ERBE, WITH NO CHANGE. THE TSE WALKED THE CALLER THROUGH A POWER CYCLE OF THE DA VINCI, WITH NO CHANGE. THE TSE WALKED THE CALLER THROUGH RESEATING OF THE PERMANENT CAUTERY HOOK INSTRUMENT ON USM4, WITH A RESEAT OF THE STERILE ADAPTER, WITH NO CHANGE. THE TSE HAD THE CALLER MOVE THE PERMANENT CAUTERY HOOK FROM USM4 TO USM2, WITH NO CHANGE. THE TSE HAD THE CALLER INSTALL A 3RD PERMANENT CAUTERY HOOK INSTRUMENT, AND MONOPOLAR CABLE, WITH NO CHANGE. THE TSE SUGGESTED A 3RD PARTY CAUTERY DEVICE BE USED AND THE SURGEON OPTED TO CONVERT TO LAPAROSCOPIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330044 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A

    Patients

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