BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17589917 · Received August 21, 2023

    Report

    Report Number
    2955842-2023-17883
    Event Type
    Injury
    Date Received
    August 21, 2023
    Date of Event
    March 22, 2023
    Report Date
    July 27, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION GATHERED, THERE IS NO INDICATION OR REPORT THAT DAVINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENTS. THEREFORE, NO PRODUCTS ARE EXPECTED TO BE RETURNED FOR EVALUATION AND THE ROOT CAUSE OF THE CUSTOMER REPORTED POSTOPERATIVE INCIDENT CANNOT BE DETERMINED. ARTICLE CITATION: SAADOUN, JE., VANBRUGGHE, C., FARA, R. ET AL. ROBOTIC RIGHT POSTERIOR SECTIONECTOMY BY INTRAFASCIAL APPROACH FOR PANCREAS NEUROENDOCRINE LIVER METASTASIS. ANN SURG ONCOL 30, 4276 (2023). AVAILABLE AT: HTTPS://DOI.ORG/10.1245/S10434-023-13272-2.

    Additional Manufacturer Narrative · 0

    A VIDEO REVIEW WAS PERFORMED AND AND CONFIRMED DA VINCI XI WAS USED FOR THE REPORTED PROCEDURE. IN THE VIDEO, THERE WAS NO INDICATION THAT DA VINCI PRODUCT MALFUNCTIONED DURING THE PROCEDURE THAT COULD HAVE CONTRIBUTED TO THE REPORTED POST-OPERATIVE BILIARY FISTULA NOR ANY INTRA-OPERATIVE COMPLICATIONS WERE OBSERVED.

    Description of Event or Problem · 0

    DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿ROBOTIC RIGHT POSTERIOR SECTIONECTOMY BY INTRAFASCIAL APPROACH FOR PANCREAS NEUROENDOCRINE LIVER METASTASIS ¿, THE FOLLOWING EVENT WAS REPORTED. A PATIENT WHO HAD A PANCREATIC NEUROENDOCRINE TUMOR WITH SYNCHRONOUS LIVER METASTASES UNDERWENT A DA VINCI ASSISTED POSTERIOR SECTIONECTOMY ASSOCIATED WITH A WEDGE RESECTION IN SEGMENT 8. THE OPERATION WAS 330MIN AND THE ESTIMATED BLOOD LOSS WAS REPORTED 50ML. POST-OPERATIVELY, PATIENT HAD DEVELOPED GRADE B BILIARY FISTULA. THE PATIENT WAS DISCHARGED TEN DAYS LATER. THERE WAS NO MENTION OF MALFUNCTION OF DA VINCI PRODUCTS, OR ANY INTRA-OPERATIVE COMPLICATIONS IN THE ARTICLE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279256 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES