BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 20518260 · Received October 23, 2024

    Report

    Report Number
    2955842-2024-20987
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    September 29, 2024
    Report Date
    September 29, 2024
    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
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE COMPLETED THE RIGHT MASTER TOOL MANIPULATOR (MTMR) CALIBRATION AND PASSED. THE AXIS 1 OF THE PATIENT SURGICAL MANIPULATOR (PSM) 1 FAILED THE FRICTION TEST. WHEN THE FSE EXCHANGED PSM 1 WITH PSM 3, THE VISCOUS DRAG FRICTION PEAK VALUE WAS 1.2012. THE FSE REPLACED THE PSM TO CORRECT THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA). THE PSM WAS ANALYZED, AND THE REPORTED FAILURE WAS ABLE TO BE REPRODUCED DURING THE FRICTION TEST (VIA MATLAB).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE PATIENT SURGICAL MANIPULATOR (PSM) 1 HAD UNINTUITIVE MOTION. THE CUSTOMER USED A DIFFERENT INSTRUMENT ON PSM 1 BUT THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2580677 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-15 N/A 00886874110690

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES