BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 18161451 · Received November 17, 2023

    Report

    Report Number
    2955842-2023-20428
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    October 27, 2023
    Report Date
    October 27, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K140553
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. AT THIS TIME, SPECIFIC PROCEDURAL DETAILS SUCH AS EVENT DATES ARE NOT KNOWN; THEREFORE, SYSTEM AND INSTRUMENT LOGS ARE UNABLE TO BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN OBSERVED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON INFORMED THE INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVES ABOUT RECURRENT INCIDENCES OF PATIENT INJURY INVOLVING THE 12MM CANNULA THAT IS PLACED LATERALLY IN THE 8TH INTERCOSTAL SPACE (ICS) DURING PULMONARY LOBECTOMY CASES. INJURIES INCLUDE PORT SITE BRUISING, ABRASIONS AND HAIRLINE FRACTURES IN 25% OF PATIENTS. PER THE SURGEON, THIS IS DUE TO THE CANNULA RUBBING AGAINST THE RIB (INTERNALLY) ABOVE THE ICS WHEN ANGLING UPWARDS. THIS RECURRENT ISSUE WAS THE FOCUS OF AN INTERNAL STUDY CONDUCTED BY SITE RADIOLOGISTS. ADDITIONALLY, PATIENTS EXPERIENCED POST-OPERATIVE PAIN. DURING FOLLOW UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR), IT WAS STATED THAT THE BRUISING AND HAIRLINE FRACTURE IS OCCURRING DESPITE CORRECT USE OF THE REMOTE CENTER CANNULA INDICATORS AND WAS SAID THAT IT WAS TYPICALLY CAUSED BY THE ANGLE NEEDED ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) DURING STAPLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858454 DA VINCI STAPLER CANNULA NAY INTUITIVE SURGICAL, INC 470375 N/A

    Patients

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