BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16972041 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14459
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    June 28, 2021
    Report Date
    June 28, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 REPORTED COMPLAINT WAS REPRODUCED DURING FIELD EVALUATION. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS REPLACED TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED COMPLAINT WAS CONFIRMED DURING FAILURE ANALYSIS. THE UNIT FAILED THE NORMAL MODE AND TRIGGERED 319 ERROR POINTING TO PARALLELOGRAM FIBER CABLE. FURTHER INVESTIGATION, JUMPED A TEST FIBER CABLE FROM AXES CONTROLLER MOTOR (ACM) PRINTED CIRCUIT ASSEMBLY (PCA) TO AXES CONTROLLER SPAR (ACS) PCA AND FIXED THE ISSUE. RECONNECTED THE ORIGINAL PARALLELOGRAM FIBER CABLE AND THE 319 ERROR OCCURRED AGAIN. THE UNIT WAS ALSO TESTED ON PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WITH THE TEST FIBER CABLE AND PASSED DIRECTION TEST, FAN TEST, FIBER TEST, SINE CYCLE, BRAKE TESTS, AND CARRIAGE SWITCHES. ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY - BENIGN SURGICAL PROCEDURE, THE SYSTEM REFLECTED ERROR 307 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 3. PRIOR TO CALLING FOR TECHNICAL SUPPORT, THE CUSTOMER RESTARTED THE SYSTEM, BUT USM 3 WAS STILL ALARMING RED. THEY DECIDED TO DISABLE THE USM AND PROCEED WITH SURGERY. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS ARE SHOWING ERROR 25730 POINTING TO AXES CONTROLLER SPAR (ACS) USM 3 FOLLOWED BY ERROR 307 POINTING TO AXES CONTROLLER CARRIAGE (ACC) AND ACS ON USM 3. AFTER RESTARTING, THE SYSTEM CAME UP WITH ERROR 319 POINTING TO ACS AND ACC ON USM3, AND USER DISABLED THE USM. THE PROCEDURE CONTINUED AS PLANNED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863394 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-36 N/A 00886874110720

    Patients

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