BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16886863 · Received May 8, 2023

    Report

    Report Number
    2955842-2023-12947
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    April 13, 2023
    Report Date
    April 13, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS RETURNED FOR FAILURE ANALYSIS. THE REPORTED ISSUE WAS CONFIRMED. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM AND ERROR 26016 WAS TRIGGERED. THE USM FAILED THE CARRIAGE FRICTION TEST. DEBRIS CONTAMINATION WAS FOUND IN THE CARRIAGE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT UNIVERSAL SURGICAL MANIPULATOR (USM) 3 ADVANCED ON ITS OWN AND FAULTED, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND REPLACED USM 3. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS AND ITS IN PROGRESS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE UNIVERSAL SURGICAL MANIPULATOR (USM) MOVED WITH UNINTUITIVE MOTION. POOR USM CONTROL COULD RESULT IN UNINTUITIVE MOTION AND SUBSEQUENT TISSUE DAMAGE. AT THIS TIME, THE ROOT CAUSE OF THE FAILURE IS UNKNOWN. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARAOESOPHAGEAL HIATAL HERNIA SURGICAL PROCEDURE THAT ARM 3 ADVANCED ON ITS OWN AND HAD A RECOVERABLE FAULT. THE CUSTOMER RECOVERED THE FAULT AND CONTINUED TO OPERATE. THE INTUITIVE TECH SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND ERRORS 23068 AND 32098 AGAINST THE MOTOR IN ARM 3. THERE WERE NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877669 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.