BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 14539076 · Received May 29, 2022

    Report

    Report Number
    2955842-2022-11889
    Event Type
    Malfunction
    Date Received
    May 29, 2022
    Date of Event
    April 29, 2022
    Report Date
    April 29, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115374
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 COMPLAINT. THE FSE NOTED THE 22005 AND 23003 IN THE LOGS WHICH POINTS TO A HOMING ISSUE. THE FSE CONTACTED ROBOTICS COORDINATOR (ROCO) TO ASK HER IF ANYTHING WAS BLOCKING THE MASTER TOOL MANIPULATOR (MTM) OR IF THE MTM WAS IN A WEIRD POSITION DURING HOMING. THE ROCO STATED THAT SHE WAS NOT IN THE ROOM WHEN IT OCCURRED. THE FSE DID A TEST DRIVE OF THE SYSTEM AND COULD NOT REPLICATE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE EVENT WAS VERIFIED BY THE TECH SUPPORT ENGINEER. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: SYSTEM SERIAL #: (B)(4), AND EVENT DATE: (B)(6) 2022. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY THE FSE. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: 22005 AND 23003 INDICATING A HOMING ISSUE. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO A SECOND CONSOLE AFTER THE START OF THE PROCEDURE DUE TO THE SURGEON'S SIDE CONSOLE (SSC) WOULD NOT TAKE CARE CONTROL OF THE ARM. 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 SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE SECOND SURGEON SIDE CONSOLE (SSC) WOULD NOT TAKE CONTROL OF THE ARM. THE CUSTOMER WAS USING DUAL SSC AND WHEN ASSIGNING CONTROL TO SSC1, THEY WERE NOT ABLE TO TAKE CONTROL OF UNIVERSAL SURGICAL MANIPULATOR (USM4) WITH THE RIGHT MASTER. THE TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO VERIFY THAT SSC1 HAD BEEN ASSIGNED CONTROL OF ALL ARMS, TAP THE SIDE FOOT PEDAL TO SWITCH MASTER ASSIGNMENT, VERIFY THE SURGEON HEAD WAS IN HEADREST, AND THAT THEY WERE MATCHING FINGER GRIPS. THERE WAS NO CHANGE AFTER COMPLETING THESE TROUBLESHOOTING STEPS. THE CUSTOMER STATED THAT WHEN THEY ASSIGNED CONTROL TO SSC 1, THE RIGHT MASTER RETRACTED BACK INTO ITS STOWED POSITION. THE TSE ASKED IF THE CUSTOMER HAD RESEATED THE INSTRUMENT AND STERILE ADAPTER ON USM4. THE CUSTOMER STATED THEY HAD AND NO CHANGE USING SSC 1, BUT IT WAS WORKING WITHOUT ANY ISSUES ON THE SSC 2. THE CUSTOMER STATED THAT THEY WERE NOT GETTING ANY ERRORS. THE TSE VERIFIED THERE WERE NO ERRORS IN THE LOGS. THE CUSTOMER WAS USING SSC2 AND CONTINUED WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) 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
    2811583 DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380723-11 N/A 00886874115374

    Patients

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