BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 20467871 · Received October 16, 2024

    Report

    Report Number
    2955842-2024-20676
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 24, 2024
    Report Date
    September 24, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 FSE WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE USM RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE USM WAS ANALYZED AND THE REPORTED FAILURE WAS NOT CONFIRMED AS HAVING OCCURRED IN THE FIELD AND NOT REPLICATED. LOGS RECORDED ERROR 40100 COUPLED WITH ERRORS 32114 AND 32097 WHICH POINTS TO THE CLOCK SPRING. UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WITH NO TRIGGERED ERRORS. UNIT WAS ALSO TESTED ON A PFTP WHERE ALL TEST PASSED. AS A PRECAUTION, THE CLOCK SPRING ASSEMBLY WILL BE REPLACED. THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THERE WAS REPEATED RECOVERABLE FAULT 40100 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1. USM 1 WAS RED AND WAS UNUSABLE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND ERROR 25730 POINTING TO MOTOR AXIS ERROR ON AXES CONTROLLER, ARM (ACA) ON USM 1. THE TSE GUIDED THE CALLER THROUGH HARD POWER CYCLE AND EMERGENCY POWER OFF (EPO) ON PATIENT SIDE CART (PSC). THE SYSTEM STARTED NORMALLY WITH NO ERRORS, BUT AS SOON AS USM 1 WAS MOVED, THE ERROR SHOWED UP AGAIN. THE TSE ASKED THE CALLER IF THE CUSTOMER COULD PROCEED WITH 3 USMS, WHICH WAS THE CASE. USM1 WAS DISABLED, AND SURGERY WAS RESUMED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033755 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-48 N/A 00886874115404

    Patients

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