BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 18039336 · Received October 31, 2023

    Report

    Report Number
    2955842-2023-19802
    Event Type
    Injury
    Date Received
    October 31, 2023
    Date of Event
    October 2, 2023
    Report Date
    October 2, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110690
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WAS ABLE TO REPRODUCE THE REPORTED ISSUE AND REPLACED PSM #2 TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE PSM INVOLVED WITH THIS COMPLAINT; HOWEVER, EVALUATION/INVESTIGATION HAS NOT BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PATIENT SIDE MANIPULATOR (PSM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS WAS ABLE TO CONFIRM THE REPORTED COMPLAINT UPON TESTING THE PSM DURING THE SINE CYCLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, A MESSAGE "INSTRUMENT ARM NOT FREE TO MOVE" APPEARED AFTER A FORCEPS INSTRUMENT WAS INSTALLED ON PATIENT SIDE MANIPULATOR (PSM) #2, AND THE CUSTOMER WAS UNABLE TO MOVE THE INSERTION AXIS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED THAT PSM #2 DID NOT HIT ANY OTHER OBJECT, AND THERE WAS NO RELATED ERROR IN THE LOGS. THE CUSTOMER POWER CYCLED THE SYSTEM AND PERFORMED EMERGENCY POWER OFF (EPO), BUT THE ISSUE WAS NOT RESOLVED. THE TSE ADVISED THE CUSTOMER TO DISABLE PSM. HOWEVER, THE CUSTOMER ELECTED TO CONVERT THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED AFTER PORTS WERE PLACED. THE CONVERSION TO TRADITIONAL LAPAROSCOPIC SURGERY RESULTED IN AN ADDITIONAL PORT WITH A DIAMETER OF FIVE MILLIMETERS BEING ADDED. THE PATIENT TOLERATED THE CONVERSION WELL WITHOUT ANY INJURY. THERE WAS NO POST-OPERATIVE COMPLICATION.

    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
    2128357 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-11 N/A 00886874110690

    Patients

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