BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19314876 · Received May 14, 2024

    Report

    Report Number
    2955842-2024-14377
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    April 19, 2024
    Report Date
    April 19, 2024
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) SPOKE WITH THE INITIAL REPORTER AND CONFIRMED THERE WERE NO OTHER ISSUES ON THEIR SECOND CASE WITH A NEW ENDOSCOPE. SECOND CASE LOG REVIEW REVEALED NO SYSTEM OR CAMERA RELATED ISSUES. NO SITE VISIT REQUESTED OR REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SITE HAD MULTIPLE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 FAULTS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VERIFIED 23003 ERRORS ON USM 3 (CAMERA ARM). THE TSE RECOMMENDED THE CUSTOMER MOVE TO ANOTHER ENDOSCOPE, BUT CUSTOMER HAD OPTED TO CONVERT THE PROCEDURE TO OPEN SURGERY PRIOR TO CALLING IN FOR NON-ROBOTIC RELATED ISSUES. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP 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
    583034 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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