BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16718940 · Received April 11, 2023

    Report

    Report Number
    2955842-2023-11896
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 15, 2023
    Report Date
    March 15, 2023
    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
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 WAS HAVING ISSUES, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INVESTIGATE THE REPORTED EVENT FURTHER. THE FSE FOUND THE ISSUE MAY BE DUE TO AN INSTRUMENT OR DRAPE ISSUE, HOWEVER, REPLACED THE USM FOR CUSTOMER SATISFACTION. THE SYSTEM WAS TESTED AND READY FOR USE. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE AND NO RELATED ERRORS OCCURRED. THE USM WAS ALSO TESTED ON A PSC FIXTURE TEST PLATFORM (PFTP) WERE IT FAILED ON CARRIAGE DIRECTION TEST DOF 6,7 CARRIAGE FRICTION LOW DOF 8 AND CARRIAGE FRICTION HIGH DOF 8. DURING VISUAL INSPECTION OF THE CARRIAGE THE FLAT FLEX CABLE'S (FFC) GOING TO MOTOR 2 (DOF6) WAS KINKED. A FOLD ROLLING LOOP FFC WAS USED, AND THE USM PASSED CARRIAGE DIRECTION TEST, SINE CYCLE, AND CARRIAGE STRENGTH TEST, BUT STILL FAILED CARRIAGE FRICTION LOW AND CARRIAGE FRICTION HIGH ON DOF 8. TO ADDRESS THE ISSUE OF DOF 6 AND 7 THE ROLLING LOOP ASSEMBLY WILL BE REPLACED. TO ADDRESS THE ERROR 25930 ON DOF 4 THE INSTRUMENT STERILE ADAPTER (ISA) PRINTED CIRCUIT ASSEMBLY (PCA) WILL BE REPLACED. THE COMPLAINT REGARDING THE USM HAVING ISSUES, WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE OF THE USM ISSUE IS ATTRIBUTED TO A COMPONENT FAILURE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: A UNIVERSAL SURGICAL MANIPULATOR 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 UMBILICAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER REPORTED PROBLEMS WITH UNIVERSAL SURGICAL MANIPULATOR (USM) 2. PRIOR TO CALLING, THE CUSTOMER HAD A FORCE BIPOLAR INSTRUMENT INSTALLED, WHICH WAS NOT CLOSING COMPLETELY. THE STAFF REPLACED IT WITH A BACKUP FORCE BIPOLAR, BUT THE ISSUE PERSISTED. THE CALLER THEN RESEATED THE STERILE ADAPTER WHILE PUSHING DOWN ON THE DISCS, WHICH CAUSED THE INSTRUMENT TO CLOSE SLOWLY AND SHAKILY. CONSEQUENTLY, THE SITE UNDOCKED USM 2 AND REPLACED IT WITH USM 1, WHICH RESOLVED THE ISSUE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS UNABLE TO ACCESS THE SYSTEM LOGS DUE TO THE LACK OF ON-SITE CONNECTIVITY. THEREFORE, THE TSE RECOMMENDED THAT THE CALLER INSPECT USM 2 AFTER THE CASE TO IDENTIFY ANY DAMAGE OR DEBRIS THAT COULD CAUSE IMPROPER ENGAGEMENT. ADDITIONALLY, THE TSE ADVISED CHECKING THE PRESENCE PINS AND ENSURING THAT THEY ARE NOT STICKING OR EXPERIENCING FRICTION. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019601 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-55 N/A 00886874110720

    Patients

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