BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 16754699 · Received April 17, 2023

    Report

    Report Number
    2955842-2023-12007
    Event Type
    Injury
    Date Received
    April 17, 2023
    Date of Event
    March 20, 2023
    Report Date
    March 20, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110690
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THERE IS NO CLAIM AGAINST THE PRODUCT AND NO INDICATION OF A PRODUCT ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THE ADVERSE EVENT. BASED ON THE INVESTIGATION, THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE CONVERT TO OPEN. WHILE THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED DURING THE PROCEDURE, THE USE OF DA VINCI PRODUCTS DURING THIS TYPE OF SURGICAL PROCEDURE MAY HAVE CONTRIBUTED TO THE INTRAOPERATIVE COMPLICATIONS AS NOTED IN THE SURGICAL RISK DOCUMENT (1009326). INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THERE IS NO INDICATION THAT THE DA VINCI PRODUCTS THEMSELVES CAUSED THE INJURY. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO OPEN AFTER THE START OF THE PROCEDURE DUE TO ANATOMY. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PROCEDURE WAS CONVERTED TO OPEN BECAUSE THE DOCTOR COULD NOT FIND ANY ANATOMICAL PLANE IN ORDER TO IDENTIFY THE NECK OF THE BLADDER OR THE PROSTATE. THE PROCEDURE WAS CONVERTED TO OPEN WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT EXTENSIVE ADHESIONS WERE THE REASON THE SURGEON CONVERTED TO OPEN AND HE WAS NOT EXPECTING TO CONVERT BEFORE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT, JUST MORE TIME ANESTHETIZED AND WITH MORE BLEEDING. THE SYSTEM WAS INSPECTED BEFORE THE PROCEDURE WITH NO ISSUES NOTED. THE TOTAL TIME OF THE SURGERY WAS APPROXIMATELY 3 HOURS. THE BLEEDING WAS NOT THE REASON TO CONVERT, HE CONVERTED THE SURGERY BECAUSE THE SURGEON COULD NOT FIND THE CORRECT PLANE OF THE PATIENT, THE ANATOMY WAS TOO MODIFIED, AND IT HAD SO MANY ADHERENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322593 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-15 N/A 00886874110690

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES.