BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17999884 · Received October 24, 2023

    Report

    Report Number
    2955842-2023-19556
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    September 29, 2023
    Report Date
    September 29, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED GENERAL SIGMOID COLECTOMY SURGICAL PROCEDURE, AFTER COMPLETION OF THE ROBOTIC PORTION OF THE PROCEDURE, THE PATIENT SIDE CART (PSC) WAS UNDOCKED AND THE SURGEON BEGAN LAPAROSCOPIC PORTION, WHILE CLEANING WITH A Q-TIP THE TOP PORTION FELL OFF INTO THE PATIENT'S ABDOMEN. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE QTIP PART FELL INTO THE PATIENT AND THERE WERE NO NEEDLES INVOLVED. THE FRAGMENT WAS RETRIEVED LAPAROSCOPICALLY. THE PATIENT DID NOT RETURN TO THE HOSPITAL. THE SURGEON WAS HOLDING THE QTIP FOR CLEANING THE SURGICAL FIELD. THE LAPAROSCOPIC PORTION OF THE PROCEDURE WAS A PLANNED PART OF THE PROCEDURE. NO PROCEDURE CONVERSION HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579034 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A

    Patients

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