BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 20824570 · Received December 2, 2024

    Report

    Report Number
    2955842-2024-22277
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    November 4, 2024
    Report Date
    November 4, 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
    IN
    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. THE FSE REPLICATED THE ISSUE AND REPLACED THE POT DUAL JDK PART TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PART DUAL JDK INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION IDENTIFIED POSSIBLE RECOVERABLE FAULTS. THE USER RECOVERED FROM THE RECOVERABLE FAULTS DURING THE CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE CUSTOMER ENCOUNTERED A REPEATED RECOVERABLE ERROR ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) #3 AND THE SURGEON WAS NOT ABLE TO CONTROL THE USM #2 AS WELL. AS A RESULT, THE PROCEDURE WAS ABORTED AFTER ANESTHESIA WAS ADMINISTERED AND PORTS HAD BEEN PLACED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUES WERE NOTED DURING THE SETUP OF THE SYSTEM WHILE DRAPING. THE PROCEDURE HAD NOT STARTED WHEN THE ISSUE OCCURRED. IT IS UNKNOWN WHAT POST-OPERATIVE COMPLICATIONS, IF ANY, THE PATIENT EXPERIENCE FOLLOWING THE PROCEDURE BEING ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328148 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-13 N/A 00886874110690

    Patients

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