BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17067638 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15842
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    October 6, 2021
    Report Date
    October 6, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    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 COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE REPORTED PROBLEM. THE FSE REPLACED TOUCH SCREEN COMPUTER ALONG WITH THE SURGEON BACK PLANE (SBP) PCA (PRINTED CIRCUIT ASSEMBLY) TO RESOLVE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE TOUCH SCREEN COMPUTER INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION REVEALED THAT THE UNIT WAS RETURNED FOR FAILURE ANALYSIS, BUT THE REPORTED FAILURE COULD NOT BE REPRODUCED. HOWEVER, THE ERROR/FAULT WAS CONFIRMED VIA ERROR LOGS/SYSTEM LOGS. REPORTED PROBLEM CONTROL LOST FROM SSC2 DURING SURGERY. VISUAL INSPECTION FOUND THE UNIT TO BE IN GOOD CONDITION. INVESTIGATION FOUND ERROR 307 IN THE LOGS WHICH INDICATED THAT IT STOPPED RESPONDING. THE TOUCHPAD WAS INSTALLED INTO THE PCA XI TEST SYSTEM. THE UNIT POWERED UP SSC WITH NO ERRORS AND WITH GOOD VIDEO. CALIBRATION AND ALL TOUCH FUNCTIONS PASSED. NO ISSUES WERE FOUND AFTER RUNNING POWER CYCLES FOR TWO HOURS AND RUNNING NORMAL MODE OVERNIGHT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SURGEON BACK PLANE (SBP) PCA (PRINTED CIRCUIT ASSEMBLY) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION REVEALED THE UNIT WAS RETURNED FOR FAILURE ANALYSIS, BUT THE REPORTED FAILURE COULD NOT BE REPRODUCED. HOWEVER, THE ERROR/FAULT WAS CONFIRMED VIA ERROR LOGS/SYSTEM LOGS. THERE ARE TWO PARTS REPLACED FROM THE SYSTEM, THE SBP AND THE TOUCHPAD. BOTH WERE TESTED TOGETHER ON THE PCA TEST SYSTEM. THE SYSTEM STARTED UP WITHOUT ANY ERROR, WITH GOOD VIDEO. PERFORMED TOUCHPAD CALIBRATION, AND ALL TOUCH FUNCTION WAS TESTED AND PASSED. POWER CYCLES FOR TWO HOURS, THERE WAS NO ERROR. BOTH PARTS REMAINED ON THE TEST SYSTEM OVERNIGHT IN NORMAL OPERATION WHILE TESTING OTHER BOARDS AND THERE WAS NO ERROR. BOTH PARTS PERFORMED AS INTENDED. THERE WAS AN UNRELATED DAMAGE FOUND ON THE SBP J44 CONNECTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ROBOTIC COORDINATOR (ROCO) CALLED IN TO REPORT THAT CONTROL WAS LOST FROM SURGEON SIDE CONSOLE (SSC2) DURING SURGERY. CALLER REPORTED THAT SURGEON HAD TO SWITCH TO SSC1 TO RECOVER THE UNIVERSAL SURGICAL MANIPULATORS (USM) CONTROL. CALLER REQUESTED A LOGS REVIEW. ROCO WAS NOT IN THE OR. TECHNICAL SUPPORT ENGINEER (TSE) REVIEW THE LOGS AND FOUND ERROR 282 POINTING TO INSTRUMENT NOT WELL DETECTED AND/OR INSTALLED ON USM2 AND INFORMED REPORTER THAT THIS EVENT MAY HAVE MADE OR TEAM TO THINK THAT THEY LOST CONTROL FROM SSC2. IN ADDITION, THE TSE REVIEWED THE ARTEMIS LOGS. TSE INFORMED CALLER THAT USER WAS USING BOTH CONSOLES SINCE THE SURGERY START WITHOUT ERROR EXCEPT THE 282 ALREADY MENTIONED. TSE OFFERED A) FIELD SERVICE ENGINEER (FSE) OR CLINICAL SALES REPRESENTATIVE (CSR) TO FOLLOW UP, REPORTER REFUSED TO DO SO. ANOTHER SURGERY WAS PLANNED ON THE SAME AFTERNOON AND REPORTER WANTED TO KNOW THE STATUS OF THE SYSTEM AND THE NEXT STEPS AFTER SECOND SURGERY. TSE CALLED BACK REPORTER AND NO ISSUE REPORTED. TSE SPOKE WITH OR NURSE, WHO STATED THAT FOR 5-6 MINUTES SURGEON SEEMED TO LOSE THE CONTROL FROM SSC2, THE SURGEON SWITCHED TO SSC1 TO TAKE CONTROL OF THE USMS. TSE INFORMED NURSE THAT TO BE ON THE SAFE SIDE A CUSTOMER SHOULD HAVE A FOLLOW UP WITH FSE OR CSR. NURSE CONFIRMED THAT ONLY ONE SURGEON WAS PRESENT TODAY MORNING. NURSE ALSO CONFIRMED THE SYMPTOM LOGGED AS 282 IN SYSTEM. THE PROCEDURE WAS COMPLETED WITH SSC1 WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745121 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-06 N/A 00886874110744

    Patients

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