BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17067644 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15848
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    August 17, 2021
    Report Date
    August 17, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 COMPLAINT. THE REPORTED ISSUE WAS FIRMED VIA FIELD EVALUATION, WHICH VERIFIED THAT THE ARM SWAP PEDAL STUCK. THE FSE REMOVED AND REPLACED THE DAMAGED FOOTREST ASSEMBLY TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOOTREST ASSEMBLY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION REPRODUCED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT FOOT-REST SWAP PEDAL WAS DAMAGED¿. VISUAL INSPECTION FOUND THE SWAP PEDAL WAS BROKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED COLOSTOMY CLOSURE SURGICAL PROCEDURE, THE SURGEON SITE CART (SSC) - FOOT-REST SWAP PEDAL WAS DAMAGED. THE CUSTOMER INFORMED THAT THEY WERE USING THE OTHER SSC FOR THE CASE. THE CUSTOMER PROVIDED AN IMAGE OF THE ISSUE; THE SSC FOOT-REST SWAP PEDAL WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) MANAGER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON MOVED OVER TO THE OTHER SCC PRIOR TO CALLING INTO DVSTAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745127 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-13 N/A 00886874110744

    Patients

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