BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14013384 · Received April 5, 2022

    Report

    Report Number
    2955842-2022-10897
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    March 7, 2022
    Report Date
    March 7, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED/REPLICATED THE REPORTED COMPLAINT. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED NORMAL MODE AS IT TRIGGERED ERROR 319. THE UNIT FAILED ON A TEST PLATFORM AS IT FAILED THE FIBER TEST ON THE ROLLING LOOP. THE ROLLING LOOP FIBER CABLE WAS SWAPPED WITH A NEW ONE AND THE ERROR NO LONGER OCCURRED. THE ORIGINAL ROLLING LOOP WAS REINSTALLED AND ERROR 319 RETURNED. THE UNIT WAS TESTED ON A TEST PLATFORM WITH A ROLLING LOOP FIBER CABLE AND PASSED DIRECTION TEST, LISSAJOUS, CHIPENCODER VIRTUAL ABSOLUTE (CVA) CHARACTERIZATION, SINE CYCLE, CARRIAGE FRICTION TEST, BRAKE RELEASE TEST, BRAKE HOLD TEST, ADVANCED BRAKE TEST, CARRIAGE STRENGTH TEST, AND CARRIAGE SWITCHES TEST. THE ROLLING LOOP ASSEMBLY WILL BE REPLACED AS A FIX TO THE REPORTED PROBLEM. THE SPAR ASSEMBLY WILL BE REPLACED AS PART OF THE UPGRADE, WHICH WILL INCLUDE A NEW ROLLING LOOP ASSEMBLY. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS PROVIDED FOR REVIEW. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: 25732 (UCE2 ON UMC1 RECEIVED AN INCONSISTENT MAXM (MOTOR AXIS MESSAGE) COUNT ON ACC (CARRIAGE ENCODERS), ARMNET2), 32114 (AURORA COMMUNICATION LINK ERROR REPORTED BY ACS IN USM2 (DOWNSTREAM COMM. LINK TO ACC IN USM2)), 319 (NODE 186 IS NOT PRESENT AT STARTUP, NODE NAME: ACC IN ARMNET2)). THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: A USM WAS DISABLED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY USING 3 ARMS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED COLORECTAL SURGICAL PROCEDURE, THE SYSTEM FAULTED. THE CUSTOMER POWER CYCLED THE SYSTEM AND GOT ERROR 319 AT ARM #2. THE CUSTOMER DISABLED ARM #2. THE SITE CONTINUED TO COMPLETE THE PROCEDURE AS PLANNED WITH ARM 2 DISABLED, WITH NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE DA VINCI COORDINATOR AND CONFIRMED THAT THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77720 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-20 N/A

    Patients

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