BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18588676 · Received January 26, 2024

    Report

    Report Number
    2955842-2024-10718
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    January 3, 2024
    Report Date
    January 3, 2024
    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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTAL SETUP JOINT (SUJ) HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS ABLE TO CONFIRM AND REPRODUCE THE ISSUE. THE AXES CONTROLLER TORNADO (ACT), WIRE HARNESS AND SETUP FRU LOWER (SFL) ON THE DISTAL SUJ WERE DEFECTIVE. THE UNIVERSAL SURGICAL MANIPULATOR (USM) HAS BEEN EVALUATED BY THE FA TEAM. FA WAS NOT ABLE TO REPRODUCE THE REPORTED ISSUE. REVIEW OF THE SYSTEM LOGS CONFIRMED NO RELATED ERROR. FA CONFIRMED NO FUNCTIONAL ISSUE. THE PROXIMAL SUJ HAS BEEN EVALUATED BY THE FA TEAM. FA WAS NOT ABLE TO REPRODUCE THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. DURING FIELD EVALUATION, FSE CONFIRMED THE ISSUE AND REPLACED THE DISTAL AND PROXIMAL SET-UP JOINT (SUJ) AND UNIVERSAL SIDE MANIPULATOR (USM) ARM 4. AFTER REPLACEMENT, THE DA VINCI SYSTEM WAS RECALIBRATED, TESTED, OPERATED WITHOUT ERROR AND VERIFIED READY FOR USE. ISI HAS RECEIVED THE REPLACED PARTS; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED POST FAILURE ANALYSIS EVALUATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SALPINGO-OOPHRECTOMY SURGICAL PROCEDURE, THE SYSTEM DISPLAYED MULTIPLE ERROR CODE 319. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). THE CUSTOMER POWER CYCLED THE SYSTEM SEVERAL TIMES AND PERFORMED AN EMERGENCY POWER OFF (EPO); HOWEVER, THE ERROR FAULT REMAINED PERSISTENT. THE USER CONTINUED WITH THE PROCEDURE UNDER THIS CONDITION. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356862 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-55 N/A 00886874110720

    Patients

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