BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16971878 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14346
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    August 2, 2021
    Report Date
    August 2, 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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE CONFIRMED THE REPORTED PROBLEM AND REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM) 4 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. THE REPORTED ERRORS 23138 AND 23069 ON THE INSERTION AXIS WERE CONFIRMED AND REPLICATED. THE UNIT GENERATED THE ERRORS DURING NORMAL MODE. HEAVY CONTAMINATION WAS FOUND ON THE CHIPENCODER VIRTUAL ABSOLUTE (CVA) DISC AND SPECKS WERE FOUND ON THE PRINTED CIRCUIT ASSEMBLY (PCA). A NEW CVA DISC WAS INSTALLED, AND THE ERRORS WENT AWAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY, UNIVERSAL SURGICAL MANIPULATOR (USM) 4 HAD AN ERROR. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED ERROR 23138 IN THE SYSTEM LOGS. A POWER-CYCLE AND DRAPE REPLACEMENT WERE PERFORMED, HOWEVER THAT DID NOT RESOLVE THE ISSUE. THE TSE ADVISED THE CUSTOMER THROUGH AN EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC) WITH NO CHANGE. THE CALLER WAS WALKED THROUGH DISABLING USM 4. THE CUSTOMER STATED THAT THEY WOULD CONTINUE WITH THE PROCEDURE AS PLANNED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781624 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

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