BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23937351 · Received December 31, 2025

    Report

    Report Number
    2955842-2025-50231
    Event Type
    Malfunction
    Date Received
    December 31, 2025
    Date of Event
    December 11, 2025
    Report Date
    January 23, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVE THE E-200 GENERATOR INVOLVED IN THIS EVENT BUT NOT THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. THE E-200 WAS VISUALLY INSPECTED, WHERE NO ISSUES WERE FOUND. THE UNIT WAS INSTALLED ONTO A KNOWN GOOD SYSTEM AND POWERED ON WITH NO ISSUES. THE UNIT PASSED SYSTEM DRIVE TESTING. THE UNIT PASSED FUNCTIONAL TESTING. THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE FAILURE ANALYSIS FOUND NO ISSUES WITH THE E-200 GENERATOR AND THE MCS WAS NOT RETURNED, THE INFORMATION GATHERED CAN'T CONFIRM NOR DENY THAT THE REPORTED DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. SINCE THE MCS WAS NOT RETURNED AND THE SYSTEM LOG REVIEW DIDN¿T SHOW ANY RELATED ERRORS, THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED OR REPLICATED.

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. FSE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. FSE REPLACED PN: 374897-33 E-200 GENERATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. 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 THE SURGEON EXPERIENCED SPARKING DURING THE COLPOTOMY PORTION OF THE PROCEDURE. THE ISSUE WAS NOTED TO HAVE OCCURRED MULTIPLE TIMES WITH VARIOUS SURGEONS. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. THE INSTRUMENT THAT ISSUE OCCURRED WITH WAS A MCS INSTRUMENT. THE INSTRUMENT WAS INSPECTED BEFORE AND AFTER AND NO NOTABLE DAMAGE WAS SEEN ON THE INSTRUMENT. IT WAS DURING COLPOTOMY, SO IT WAS CLOSE OR AT TIMES TOUCHING THE KOH RING OF THE AVINCULA MANIPULATOR. THE INSTRUMENT TIP(S) DID NOT TOUCH ANY STAPLES, CLIPS OR SUTURES WHILE ENERGIZED. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS AS A RESULT OF THE ARCING EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2529743 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23

    Patients

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