BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 20413793 · Received October 9, 2024

    Report

    Report Number
    2955842-2024-20278
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    September 13, 2024
    Report Date
    September 13, 2024
    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
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PATIENT SIDE MANIPULATOR (PSM) FOR FAILURE ANALYSIS EVALUATION. THE PSM WAS ANALYZED AND A VISUAL INSPECTION WAS PERFORMED. THE ARM WAS INSTALLED ONTO A SYSTEM AND POWERED UP. NO FAILURES WERE WERE FOUND.

    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. THE FSE REPLACED THE PATIENT SIDE MANIPULATOR (PSM) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS NOT RECEIVED THE PSM FOR EVALUATION AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, A NURSE CALLED IN TO REPORT AN ERROR ON PATIENT SIDE MANIPULATOR (PSM) 1. THE CUSTOMER HAD ALREADY POWER CYCLED THE SYSTEM. THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED LOGS AND FOUND ERRORS NOTING THAT PSM 1 INITIALIZATION FAILED DURING STARTUP AND ALSO THAT THE CANNULA PORT CLUTCH WAS STUCK. THE TSE GUIDED THE CALLER TO HARD POWER CYCLE WHILE PRESSING THE CLUTCH BUTTON ON PSM 1, AND THEN TO RESEAT THE INSTRUMENT. AFTER THE SYSTEM POWERED UP, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS ABORTED POST ANESTHESIA AND PORT PLACEMENT. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION. THE PROCEDURE HAD BEEN UNDER WAY FOR ABOUT HALF AN HOUR AT THE CONSOLE WHEN THE ISSUE STARTED. APART FROM THE CANCELLATION OF THE PROCEDURE, WHICH HAD TO BE RESCHEDULED, THERE WERE NO OTHER INCIDENTS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957265 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-10 N/A 00886874110690

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other DA VINCI INSTRUMENTS AND ACCESSORIES.