BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15982217 · Received December 14, 2022

    Report

    Report Number
    2955842-2022-15892
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    November 14, 2022
    Report Date
    November 14, 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
    MD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE MADE A SITE VISIT TO TROUBLESHOOT THE LACK OF IMAGE IN THE RIGHT EYE OF THE SSC. THE IMAGE WAS ONLY OUT WITHIN THE SSC AND WAS ON NO OTHER MONITOR IN THE ROOM, WHICH INDICATED THAT THE REPORTED PROBLEM WAS ISOLATED TO THE SSC. THE FSE SWAPPED THE DVI CABLES BETWEEN THE LEFT EYE AND RIGHT EYE ON THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) AND FOUND THAT THE RIGHT EYE IMAGE WAS STILL OUT INDICATING THE PROBLEM IS ISOLATED TO THE RIGHT SIDE MONITOR WITHIN THE SSC. THE FSE REPLACED BOTH SSC MONITORS TO RESOLVE ISSUE DUE TO VIRTUAL SUPPORT REQUIREMENTS TO KEEP BOTH MONITOR PART NUMBERS CONSISTENT. THE MONITORS WERE REPLACED. IMAGE WAS AVAILABLE IN BOTH EYES FOLLOWING THE REPLACEMENT. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT REGARDING SSC HAVING A BLACK EYE WAS CONFIRMED BASED ON THE FIELD EVALUATION WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE FIRST HIGH RESOLUTION STEREO VIEWER (HRSV) UNIT INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED FOR EVALUATION. FAILURE ANALYSIS REPLICATED THE CUSTOMER REPORTED COMPLAINT. THE MONITOR WAS INSTALLED AND TESTED IN THE PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM, THE SYSTEM STARTED UP AND THE MONITOR STAY BLACK WITHOUT VIDEO. THE SECOND HRSV UNIT INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED FOR EVALUATION. FAILURE ANALYSIS WAS NOT ABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE MONITOR WAS INSTALLED ONTO THE PCA SYSTEM, THE SYSTEM STARTED UP WITHOUT ANY ERRORS, 10 POWER CYCLES WERE PERFORMED WITHOUT ANY ISSUES ALSO BOOTED UP THE SYSTEM IN NORMAL MODE AND LET IT IDLE FOR 10 MINUTES WITHOUT ISSUES. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. A PROCEDURE LOG REVIEW WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: A SIMPLE PROSTATECTOMY PROCEDURE WAS PERFORMED ON SYSTEM (B)(4) ON (B)(6) 2022. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO SURGEON SIDE CONSOLE HAVING A BLACK EYE. 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 CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SIMPLE SURGICAL PROCEDURE, THE CUSTOMER CALLED IN THAT ONE OF THEIR SURGEON SIDE CONSOLES (SSC) HAD A BLACK EYE. THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE LOGS AND FOUND NO ASSOCIATED FAULTS. TSE ADVISED THE CUSTOMER TO POWER CYCLE THE SYSTEM. THE CUSTOMER WAS ALREADY IN THE PROCEDURE AND THE SURGEON MOVED TO THEIR SECONDARY SSC. THE CUSTOMER WILL POWER CYCLE AFTER THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: PER THE CUSTOMER, THERE IS NO PATIENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051762 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-03 N/A

    Patients

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