BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21588881 · Received March 12, 2025

    Report

    Report Number
    2955842-2025-07398
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    February 19, 2025
    Report Date
    February 19, 2025
    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
    CH
    Reporter Occupation
    003

    Narratives

    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. FSE WAS NOT ABLE TO REPRODUCE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE.

    Additional Manufacturer Narrative · 0

    THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE TO THE YAW PULLEY. THE YAW PULLEY WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING OF BOTH BIPOLAR YAW PULLEYS, IN THE SPA BETWEEN THE GRIPS. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. COMMON CAUSES OF THE FAILURE MODE THERMAL DAMAGE BETWEEN GRIPS INSTRUMENT BIPOLAR YAW PULLEY ARE ATTRIBUTED TO INSULATION DEGRADATION AND CARBONIZED TISSUE CREATING A CONDUCTIVE PATH.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: AN ESU GENERATOR WAS USED. COAGULATION WAS SET TO 4 (80W). AFTER FURTHER REVIEW OF THE COMPLAINT INFORMATION, THERE WAS INSUFFICIENT INFORMATION TO DETERMINE THE BIPOLAR INSTRUMENT ASSOCIATED WITH THE EVENT. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED SINCE THERE WAS INSUFFICIENT INFORMATION TO DETERMINE THE INSTRUMENT USED WITH THE PROCEDURE. CORRECTION: THE INSTRUMENT HAS BEEN UPDATED TO N/A (FOR REGULATORY USE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL LIVER RESECTION PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THE VIO INTEGRATED ELECTROSURGICAL UNIT (IESU) FOUND INSTRUMENT ARCING. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE TECH SUPPORT INFORMED THE CUSTOMER OBSERVED THE BIPOLAR ARCING. THE FRONT END OF BIPOLAR INSTRUMENT WAS DAMAGED. THE CUSTOMER DID NOT INSPECT THE CANNULA. THE ARCING ORIGINATED FROM THE FRONT END OF THE BIPOLAR AND THE ARC GROUND ADJACENT ELECTRODE. THE INSTRUMENT WAS CONNECTED PROPERLY. THE INSTRUMENT WAS USED FOR ABOUT AN HOUR THEN ARCING WAS OBSERVED. WHEN ARCING OCCURRED, THE INSTRUMENT DID NOT COME IN CONTACT WITH TISSUE. THE OTHER INSTRUMENTS WERE IN USE PROPERLY AND NO ARCING.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148064 DAVINCI XI N/A NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

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