BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 22246729 · Received June 17, 2025

    Report

    Report Number
    2955842-2025-25901
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    May 30, 2025
    Report Date
    May 30, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114735
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE FSE REPRODUCED THE ERROR 22018 AT STARTUP. ERGO CAL WAS PERFORMED. BOTH DIG POT BOARD PN 351270-05 REPLACED TO CORRECT ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PART INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A MALFUNCTION OR MISCONFIGURATION CAUSED BY ELECTRICAL ISSUES FROM THE DIGITAL POT BOARDS LOCATED WITHIN THE SSC. IT CAN BE RESOLVED BY REPLACING THE DIGITAL POT BOARDS AND RECALIBRATING THE SSC. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. THE DIG POT BOARDS WERE SCRAP ITEMS. CUSTOMER BELIEVES ISSUE CAUSED BY DEFECTIVE COMPONENT ON THE BOARD. CUSTOMER USED 2ND SSC FOR SURGERY. BUT SSC1 COULD BE USED WITHOUT ISSUE IF SURGEON WAS OK WITH THE TILT POSITION OF THE VIEWER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL HYSTERECTOMY BENIGN PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT ERROR 22018 REMAINED. THE CUSTOMER STATED THAT THEY HAD IT SINCE THE INSTALLATION. THE CUSTOMER CALLED BACK TO REPORT THAT AN ISSUE, THAT WAS PREVIOUSLY REPORTED, HAD RETURNED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. PREVIOUSLY, THE CUSTOMER HAD ERROR 22018 POINTING TO THE HIGH-RESOLUTION STEREO VIEWER (HRSV) TILT SENSOR.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2682763 DA VINCI SP SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380940-51 N/A 00886874114735

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DA VINCI INSTRUMENTS AND ACCESSORIES