BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 18111719 · Received November 10, 2023

    Report

    Report Number
    2955842-2023-20023
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    October 16, 2023
    Report Date
    October 16, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE CUSTOMER AND SPOKE WITH THE SITE'S ROBOTICS COORDINATOR WHO INSTALLED MULTIPLE INSTRUMENTS, DRAPES, AND CANNULAS ON ARM #2 TO FIND THAT SYSTEM WAS ACCEPTING INSTRUMENTS WITHOUT ISSUE. THE CUSTOMER LIKELY DID NOT HAVE THE CANNULA ATTACHED PROPERLY CAUSING ERRORS OR POSSIBLY A BAD CANNULA. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THE SURGEON OPTED TO CONVERT TO OPEN SURGERY DUE TO ANATOMICAL DIFFICULTIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE SYSTEM WAS MALFUNCTIONING. THE ARM 2 WOULD NOT RECOGNIZE ANY INSTRUMENTS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND NOTED AN ERROR 22008 ON THE CANNULA OR INVALID CANNULA. THE PROCEDURE WAS STARTED ROBOTICALLY BUT CONVERTED TO OPEN AFTER REBOOTING THE SYSTEM AND RE-DRAPING THE ARM, BUT THE ISSUE REMAINED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM MALFUNCTIONED WITH A VESSEL SEALER EXTEND INSTRUMENT WHICH IS NOT MANUFACTURED ANYMORE. THE SURGEON WAS DECIDING WHAT TO DO WITH THE LEFTOVERS. THE PATIENT HAD NUMEROUS FIBROIDS. THE DECISION TO CONVERT THE PROCEDURE TO OPEN WAS AFTER PORTS WERE PLACED AND WAS DUE TO THE ANATOMICAL DIFFICULTIES IN THE PATIENT. THE CONVERT TO OPEN SURGERY WAS DUE TO THESE ANATOMICAL DIFFICULTIES AND NOT DUE TO THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104060 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-06 N/A

    Patients

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