BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17646943 · Received August 29, 2023

    Report

    Report Number
    2955842-2023-18076
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 7, 2023
    Report Date
    August 7, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED FAULTS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE WAS ABLE TO REPLICATE THE ERROR AFTER TURNING ON THE SYSTEM. THE FSE NOTICED THAT THE CIRCULAR UNIVERSAL SURGICAL MANIPULATOR (USM) COVER WAS MISSING, AND THE FLAT FLEX CABLE CONNECTED TO THE CHIP-ENCODER VIRTUAL ABSOLUTE (CVA) WAS DISCONNECTED. THE FSE RECONNECTED THE FLAT FLEX CABLE AND REPLACED THE CIRCULAR COVER ON THE USM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT REGARDING THE RECOVERABLE FAULT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, AN ARM WAS FAULTING. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND FOUND RECOVERABLE FAULTS AGAINST UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE TSE RECOMMENDED PERFORMING A HARD REBOOT ON THE SYSTEM BUT ADVISED THAT THE ERROR COULD RETURN. THERE WERE NO REPORTS OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED AS A 3-ARM PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058640 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-20 N/A

    Patients

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