BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16971968 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14405
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    February 18, 2021
    Report Date
    February 18, 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
    TW
    Reporter Occupation
    003

    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 GENERATED 23068 DEGREES OF FREEDOM (DOF) 7 WITH 32098 AXES CONTROLLER MOTOR (ACM) ERROR DURING NORMAL MODE. ERROR 26016 WAS ALSO GENERATED ON DOF 7 AXIS. DOF 7 ON INSTRUMENT STERILE ADAPTER (ISA) AND ROTOR FOUND WITH SIGNIFICANT DEBRIS. SWAPPED A NEW ISA PRINTED CIRCUIT ASSEMBLY (PCA) WITH NEW DOF 7 ROTOR AND THE ERROR DID NOT RETURN. AS A FIX TO THE REPORTED PROBLEM, ISA PCA, DOF 7 ROTOR WILL BE REPLACED. DOFS 5,6, 8 AND 9 CARRIAGE ROTORS HAD SURFACE CONTAMINATION, ALL OTHER FOUR CARRIAGE ROTORS WILL BE REPLACED AS A FIX. SURFACE CONTAMINATION ON DOFS 5-9 GEARBOXES WERE PRESENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, REPEATED RECOVERABLE FAULT 23087 OCCURRED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE USER TRIED TO RECOVER THE FAULT, BUT THE ISSUE PERSISTED. THE USER DISABLED USM 4 TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809188 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-37 N/A 00886874110720

    Patients

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