BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21540204 · Received March 6, 2025

    Report

    Report Number
    2955842-2025-04231
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    February 6, 2025
    Report Date
    February 6, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER POWERED CYCLED THE SYSTEM AND THIS RESOLVED THE ISSUE. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE CUSTOMER AND THE CUSTOMER CONFIRMED THE ISSUE DID NOT RETURN. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. AN ISI TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS BUT DID NOT FIND ANY ASSOCIATED ERRORS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS REVISION PROCEDURE, THERE WERE FOUR INSTANCES WHERE INSTRUMENTS WOULD NOT ENGAGE WITH THE PATIENT SIDE CART (PSC) UNIVERSAL SURGICAL MANIPULATOR (USM) ADAPTER. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) MENTIONED THAT NO ONE WAS AT THE STERILE FIELD WAS TOUCHING ANY OF THE INSTRUMENTS, AND THAT THERE WAS NO TENSION ON THE DRAPES. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) VIEWED SYSTEM LOGS BUT DID NOT FIND ANY ASSOCIATED ERRORS. THE CSR VERIFIED THAT THEY CONVERTED TO OPEN SURGERY, BUT IT WAS NOT SOLELY DUE TO THE SYSTEM ISSUE. THE CSR WOULD COMPLETE A HARD REBOOT OF THE SYSTEM AFTER THE CASE. THE SITE PROCEEDED WITH AN OPEN PROCEDURE. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435335 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

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