BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21854296 · Received April 17, 2025

    Report

    Report Number
    2955842-2025-15524
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 31, 2025
    Report Date
    March 31, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    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) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND PER THE ERROR LOG, NO DATA WAS FOUND TO INDICATE THAT THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM WHERE THE UNIT FUNCTIONED AS EXPECTED. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS. THE FAILURE ANALYSIS INVESTIGATIONS AND IN-HOUSE TESTING OF THE RETURNED PRODUCT REVEALED NO ISSUES RELATED TO THE CUSTOMER REPORTED EVENT. FURTHERMORE, THE ASSOCIATED DEVICE WAS NOT RETURNED TO ISI FOR FAILURE ANALYSIS TO BE ABLE TO ASSESS THE REPORTED FAILURE MODE.

    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 INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE UNIT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    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 LIVER RESECTION SURGICAL PROCEDURE, THE 8MM MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT WAS ARCING. PRIOR TO THE CALL, THEY ALREADY USED A NEW INSTRUMENT AND NEW CABLE WITH NO CHANGE. SHE STATED THAT THIS ALREADY HAPPENED ON LAST WEEK. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED LIVE LOGS BUT FOUND NOTHING RELEVANT. THE TSE HAD THE CUSTOMER VERIFY THE LOT NUMBER TO CHECK IF IT WAS THE SAME. ONE OF THEM WAS THE SAME BUT THE OTHER WAS NOT. THE BEHAVIOR WAS ONLY AND ALWAYS HAPPENING WITH THE MBF INSTRUMENT. THE TSE HAD THE CUSTOMER SWAP THE INSTRUMENT AND THE UNIVERSAL SURGICAL MANIPULATOR (USM) BUT THE CUSTOMER ELECTED NOT TO PERFORM THE TROUBLESHOOTING. THEY WERE USING THE BIPOLAR FORCEPS INSTRUMENT FOR NOW TO COMPLETE THE PROCEDURE. THE POWER AND THE SETTING WAS NORMAL. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681100 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 N/A

    Patients

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