BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16972011 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14434
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    April 22, 2021
    Report Date
    April 22, 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
    AZ, US
    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 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 WAS TESTED ON AN IN-HOUSE SYSTEM AND TRIGGERED 23094 ERROR IN NORMAL MODE. UNPLUGGING AND RE-SEATING THE CURRENT CHIPENCODER VIRTUAL ABSOLUTE (CVA) FLAT FLEX CABLE (FFC) DID NOT FIX THE FAULT. THE CVA2 FFC WAS REPLACED AND THE UNIT STILL FAILED. THEN, CVA2 DISK WAS FOUND WITH A HEAVY CONTAMINATION AND SCRATCHED. A NEW CVA WAS SWAPPED IN, BUT ERROR STILL RETURNED. THE CVA PCA WAS REPLACED AND THE ERROR DID NOT OCCUR. THE ORIGINAL PITCH CVA PCA WAS RE-INSTALLED AND TRIGGERED BACK THE SAME ERROR. ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY - RADICAL SALVAGE SURGICAL PROCEDURE, THERE WAS AN ERROR 23094 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER BACK DRIVE AND POWER CYCLE AND ALSO DO AN EMERGENCY POWER OFF (EPO) OF PATIENT SIDE CART (PSC) WITH NO CHANGE. THE CUSTOMER ELECTED TO DISABLE USM 4 AND CONTINUE WITH PROCEDURE AS A 3 USM SYSTEM. THE CUSTOMER REQUESTED FIELD SERVICE ENGINEER (FSE) ASSISTANCE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870865 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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