BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16971389 · Received May 21, 2023

    Report

    Report Number
    2955842-2023-14017
    Event Type
    Malfunction
    Date Received
    May 21, 2023
    Date of Event
    September 21, 2020
    Report Date
    September 21, 2020
    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
    FR
    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 REPLACED THE SYSTEM'S UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE USM TRIGGERED ERROR 23118 FAULT IN NORMAL MODE. FA OPENED THE DEGREE OF FREEDOM (DOF) 4 CHIPENCODER VIRTUAL ABSOLUTE (CVA) ASSEMBLY AND FOUND THE FLAT FLEX CABLE (FFC) (ON DOF 4 CVA SENSOR PRINTED CIRCUIT ASSEMBLY (PCA)) HAD SCRAPED/RUBBING MARK WITH EXPOSED WIRES. A NEW CVA FFC WAS SWAPPED AND THE ERROR DID NOT OCCUR. AFTER RE-INSTALLING THE ORIGINAL CVA FFC, THE ERROR RETURNED. ADDITIONALLY, THE DOF 4 CVA PCA AND CVA DISK WERE FOUND WITH SURFACE CONTAMINATION, WHICH CAUSED THE ERROR(S): 23068/23069/23087/23094, FOUND IN THE SYSTEM LOGS FROM THE FIELD. THE HALL ERRORS WERE REPLICATED DURING SINE CYCLE ON IN-HOUSE SYSTEM. AFTER SWAPPING WITH A NEW CVA PCA AND CVA DISK, THE UNIT PASSED THE SINE CYCLE WITH NO ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE SYSTEM GENERATED ERROR 23118, POINTING TO THE SYSTEM'S UNIVERSAL SURGICAL MANIPULATOR (USM) 2. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VIEWED ONSITE LOGS AND CONFIRMED SEVERAL ERROR(S): 23118, 23069, 23068, 23094 AND 1121, POINTING TO THE USM 2. THE TSE HAD THE CUSTOMER UNDOCK THE USM 2 AND POWER CYCLE THE PATIENT SIDE CART (PSC); BUT, THE ISSUE PERSISTED. THE USM 2 WAS DISABLED AND THE CUSTOMER PROCEED WITH THE PROCEDURE USING THE THREE (3) OTHER USM ARMS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781602 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-43 N/A 00886874110720

    Patients

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