BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 20861036 · Received December 6, 2024

    Report

    Report Number
    2955842-2024-22538
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    November 7, 2024
    Report Date
    November 7, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    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 WENT ON SITE AND REPLACED THE PATIENT SIDE MANIPULATOR (PSM) TO RESOLVE THE ERROR ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE PSM FOR FAILURE ANALYSIS EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT, THE EVALUATION OF THE PSM HAS NOT BEEN COMPLETED. A REVIEW OF THE SITE¿S SYSTEM LOGS WAS PERFORMED BY TECHNICAL SERVICE ENGINEER (TSE). THE TSE CONFIRMED THE ERROR ASSOCIATED WITH PSM #3 IN THE LOGS.

    Additional Manufacturer Narrative · 0

    THE PATIENT SIDE MANIPULATOR (PSM) WAS ANALYZED AND THE REPORTED ERROR ISSUE WAS UNABLE TO BE REPRODUCED; HOWEVER, THE ERRORS WERE CONFIRMED TO HAVE OCCURRED VIA THE LOGS. A VISUAL INSPECTION WAS PERFORMED. THE ARM WAS INSTALLED ONTO THE SYSTEM AND POWERED UP. MULTIPLE TESTS WERE PERFORMED AND PASSED WITHOUT ANY ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED ERRORS POINTING TO PATIENT SIDE MANIPULATOR (PSM) #3. THE ISSUE PERSISTED AFTER THE CUSTOMER REBOOTED THE SYSTEM. THE SURGEON DID NOT WANT TO WORK WITH ONLY 3 ARMS. AS A RESULT, THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO OPEN SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE. THERE WERE NO ISSUES IDENTIFIED DURING THE SYSTEM SETUP. THE CUSTOMER TOLERATED THE CONVERSION TO OPEN SURGERY AND DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201716 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-07 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES