BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 20761339 · Received November 22, 2024

    Report

    Report Number
    2955842-2024-22290
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    October 29, 2024
    Report Date
    October 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
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE COMPLAINT AND REPLACED THE PATIENT SURGICAL MANIPULATOR (PSM). THE SYSTEM WAS TESTED AND WAS VERIFIED AS READY FOR USE. ISI DID RECEIVE THE PSM TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT DURING SINE CYCLE TEST (VIA MATLAB).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL CONDUIT SURGICAL PROCEDURE, THE PATIENT SURGICAL MANIPULATOR (PSM) 3 WAS NOT FREE TO MOVE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) RECOMMENDED THE CUSTOMER TO CHECK THE PSM LED STATUS AND POWER CYCLE THE SYSTEM, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED WITHOUT PSM 3. PSM 3 WAS DISABLED SO THE CUSTOMER CONTINUED THE PROCEDURE USING PSM 1 AND PSM 2. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798013 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-14 N/A 00886874110690

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES