BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 20238668 · Received September 17, 2024

    Report

    Report Number
    2955842-2024-19481
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    August 22, 2024
    Report Date
    August 22, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    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. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) RECEIVED MESSAGE FROM THE ISI CLINICAL SALES REPRESENTATIVE (CSR), AND HE STATED THAT THE PATIENT WASN'T EVEN ABLE TO RECEIVE GAS FROM ANOTHER INSUFFLATOR THAT WAS CONFIRMED TO BE WORKING. THE ISSUE IS NOT WITH OUR INSUFFLATION BUT WITH THE PATIENT. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY - BENIGN SURGICAL PROCEDURE, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED THE SYSTEM WAS NOT ADDING GAS. THE SITE WAS USING HOUSE GAS. THE CSR STATED THAT ALL THE LIGHTS ON THE SYSTEM WERE BLUE. THEY ATTEMPTED TO POWER CYCLE, BUT THE ISSUE REMAINED. THE TECHNICAL SERVICE ENGINEER (TSE) TEAM VIEWED THE SYSTEM LOGS, AND NO ERRORS WERE NOTED. THE CSR THEN STATED THAT THE SITE¿S OTHER INSUFFLATOR SYSTEM WAS ENCOUNTERING THE SAME ISSUE. THE CSR STATED THAT THEY THOUGHT SOMETHING WAS GOING ON WITH THE HOUSE GAS AND MIGHT TRY THE TANKS. THE CSR ENDED THE CALL BEFORE THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CSR INFORMED THAT THEY WERE PRESENT FOR THE PROCEDURE. THE DA VINCI INSUFFLATOR WAS WORKING NORMALLY. THEY DID NOT SEE THE INSUFFLATOR GIVE ANY ERRORS. THE GAS WAS NOT FLOWING AS PRESSURES WERE READING 15, WHICH WAS THEIR THRESHOLD. THE TROUBLESHOOTING THAT WAS PERFORMED. THEY CHECKED THE HOUSE'S GAS, AND EVERYTHING WAS WORKING NORMALLY. THE PATIENT BODY WOULD NOT INSUFFLATE. THEY DID NOT KNOW WHY IT WOULD NOT INSUFFLATE. NO LEAKS WERE OBSERVED. THEY WERE ALSO UNABLE TO INSUFFLATE THE PATIENT BODY WITH A THIRD-PARTY INSUFFLATOR. THEY CONVERTED TO OPEN SURGERY TO CONTINUE. THERE WAS NO HARM OR INJURY TO THE PATIENT. THE CSR INFORMED THAT THERE WERE NO ISSUES WITH THE INSUFFLATOR IN THE FOLLOWING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808745 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-40 N/A 00886874119662

    Patients

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