BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16971983 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14413
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    March 11, 2021
    Report Date
    March 11, 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
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 A SYSTEM AND FAILED NORMAL MODE WITH ERRORS 319. THE UNIT FAILED ON A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) AS IT FAILED THE FIBER TEST ON THE ROLLING LOOP. THE ROLLING LOOP FIBER WAS SWAPPED WITH A NEW ONE AND THE ERROR NO LONGER OCCURRED. THE ORIGINAL ROLLING LOOP FIBER CABLE WAS REINSTALLED AND THE ERRORS RETURNED. THE UNIT WAS TESTED ON A PFTP WITH A NEW ROLLING LOOP FIBER CABLE AT PASSED THE DIRECTION TEST, LISSAJOUS, CHIPENCODER VIRTUAL ABSOLUTE (CVA) CHARACTERIZATION, SINE CYCLE, CARRIAGE FRICTION TEST, BRAKE RELEASE TEST, BRAKE HOLD TEST, ADVANCED BRAKE TEST, CARRIAGE STRENGTH TEST, AND CARRIAGE SWITCHES TEST. 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 - SIMPLE SURGICAL PROCEDURE, A NON-RECOVERABLE ERROR 319 OCCURRED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1. THE OPERATING ROOM (OR) STAFF WAS ABLE TO FINISH THE SURGERY WITH THE 3 USMS. THE TECHNICAL SUPPORT ENGINEER (TSE) VIEWED THE SYSTEM EVENT LOGS AND CONFIRMED ERRORS 319 AND 307 POINTING TO USM 1. WHEN THE ERROR CAME UP THE OR STAFF TRIED TO RESTART THE SYSTEM TWICE AT THE END OF SURGERY, BUT THEY COULD NOT RECOVER THE USM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816358 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-35 N/A 00886874110720

    Patients

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