BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17507656 · Received August 11, 2023

    Report

    Report Number
    2955842-2023-17651
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 19, 2023
    Report Date
    July 19, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE NON-INTUITIVE MOTION OF THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4, 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) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. THE ISI TSE CONFIRMED NO RELATED ERROR IN THE LOGS. 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 PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE INSTRUMENT HIT THE PATIENT CAUSING THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 TO MOVE UNINTENTIONALLY. THE DOCTOR SPECULATES THAT THE ISSUE WAS DUE TO RESPIRATORY FLUCTUATIONS, BUT THE CAUSE WAS UNKNOWN BECAUSE IT IS UNLIKELY THAT THE 4TH ARM WOULD NORMALLY CONTACT THE LUNGS/AORTA (AORTA) IN A PLACE THAT CANNOT BE SEEN. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) CONFIRMED NO RELATED ERROR IN THE LOGS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: USM 4 STARTED MOVING UP AND DOWN IN A WAVE-LIKE MOTION. THE ISSUE OCCURRED IMMEDIATELY AFTER THE SYSTEM WAS STARTED AND WHEN THE CUSTOMER WAS CHECKING THE SYSTEM. THE INSTRUMENT DID NOT COME INTO CONTACT WITH THE TISSUE OR VESSEL. THE SURGEON DID NOT KNOW THE CAUSE OF THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. THE ISSUE DID NOT RESULT IN ANY UNEXPECTED MEDICAL INTERVENTION. THE CUSTOMER WAS ABLE TO CONTINUE TO USE THE SYSTEM IN A SUBSEQUENCE PROCEDURE NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940991 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

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