BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19006178 · Received March 29, 2024

    Report

    Report Number
    2955842-2024-13005
    Event Type
    Malfunction
    Date Received
    March 29, 2024
    Date of Event
    February 22, 2024
    Report Date
    March 1, 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
    KY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) COMMUNICATED WITH CUSTOMER. CUSTOMER CONFIRMED NO ISSUES WITH THE SYSTEM AFTER MULTIPLE PROCEDURES. FSE REVIEWED LOGS. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THEY HAD A PROBLEM WITH UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THE SITE STATED THEY WERE SWAPPING INSTRUMENTS AND INSERTING THE INSTRUMENT. WHILE ADVANCING THE INSTRUMENT ON USM 3 WHEN SLIDING IT IN, THE ROBOT TOOK OVER AND KEPT PUTTING THE INSTRUMENT IN FURTHER AND WOULDN'T ALLOW THE STAFF TO PULL BACK ON THE INSTRUMENT. THE SITE COULD GET THE INSTRUMENT INSTALLED ON USM 3 AND ARE CONTINUING WITH THE CASE. TSE REVIEWED LOGS AND COULD NOT FIND ANY ERROR. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243127 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

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