BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16971694 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14251
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    November 17, 2021
    Report Date
    November 17, 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
    PA, US
    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 COMPLAINT. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) DUE TO ERROR 32101 EXPERIENCED AT SYSTEM RESTART. 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 INVESTIGATION CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED NORMAL MODE AS IT TRIGGERED 32101 ERRORS ON DEGREES OF FREEDOM (DOF) 6. THE UNIT FAILED ON A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM AS IT FAILED THE USM DIRECTION TEST AND CARRIAGE DIRECTION TEST ON DOF 6. THE DOF 6 STATOR WAS SWAPPED WITH A NEW ONE AND THE ERROR NO LONGER OCCURRED. THE ORIGINAL DOF 6 STATOR WAS REINSTALLED, AND THE ERRORS RETURNED. THE UNIT WENT THROUGH MORE TESTING ON A PSC FIXTURE TEST PLATFORM WITH A NEW DOF 6 STATOR AND PASSED LISSAJOUS, CHIPENCODER VIRTUAL ABSOLUTE (CVA) CHARACTERIZATION, SENSORS CHECK, SINE CYCLE, FRICTION TEST, CARRIAGE FRICTION TEST, BRAKE RELEASE TEST, BRAKE HOLD TEST, ADVANCED BRAKE TEST, CARRIAGE STRENGTH TEST, AND CARRIAGE SWITCHES TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED RECOVERABLE ERROR 32101 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1 THAT WOULD NOT RECOVER. THE SITE HAD RESTARTED THE SYSTEM, HOWEVER THE ERROR PERSISTED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE SITE DO A HARD RESTART OF THE PATIENT SIDE CART (PSC) WITH NO CHANGE. THE SITE CONTINUED THE PROCEDURE WITH 3 USMS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761263 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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