BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 17123807 · Received June 14, 2023

    Report

    Report Number
    2955842-2023-16296
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 15, 2023
    Report Date
    May 15, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110690
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PATIENT SIDE MANIPULATOR (PSM) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS (FA) INVESTIGATION COULD NOT REPRODUCE, NOR CONFIRM THE REPORTED ISSUE. THE PSM WAS VISUALLY INSPECTED AND EVALUATED FOR ITS MECHANICAL AND/OR ELECTRICAL CHARACTERISTICS. THE PSM WAS INSTALLED ONTO THE SYSTEM AND POWERED UP. SINE CYCLE AND A TEST DRIVE WERE PERFORMED WITHOUT ANY ISSUES. TESTS PERFORMED VIA ADDITIONAL TEST PLATFORM AND PASSED. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS. NO PRODUCT ISSUE WAS IDENTIFIED. THE FAILURE ANALYSIS INVESTIGATIONS AND IN-HOUSE TESTING OF THE RETURNED PSM REVEALED NO ISSUES RELATED TO THE CUSTOMER REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE INSTRUMENT ON THE PATIENT SIDE MANIPULATOR (PSM1) COULD NOT CUT TISSUE AND ERROR MESSAGES, AN INVESTIGATION IS IN PROGRESS. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INVESTIGATE THE REPORTED EVENT FURTHER. THE FSE FOUND AXIS 6 IS STRUGGLING WHEN ENGAGING A STERILE ADAPTER AND DOES NOT HOME AT ITS INITIAL POSITION. THE FSE REPLACED THE PSM TO RESOLVE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE PSM FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT ON THE PATIENT SIDE MANIPULATOR (PSM1) COULD NOT CUT TISSUE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VIEWED ONSITE LOGS AND NOTED ERROR 31010 POINTING TO A MISSING STERILE ADAPTER (SA). THE CUSTOMER STATED THAT ONE AXIS ON THE SA DID NOT ROTATE WHEREAS OTHERS ROTATED WITHOUT PROBLEMS. THE ISI TSE REQUESTED THE CUSTOMER TO REPLACE THE SA/DRAPE AND RESEAT THE SA OF THE NEW DRAPE SEVERAL TIMES, WHICH DID NOT SOLVE THE PROBLEM. THE PROCEDURE WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874855 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-10 N/A 00886874110690

    Patients

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