BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21077315 · Received January 6, 2025

    Report

    Report Number
    2955842-2024-23980
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 10, 2024
    Report Date
    December 10, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 WAS ANALYZED, AND THE REPORTED (INSTRUMENTS NOT RECOGNIZED ON GENERATOR) ERROR WAS CONFIRMED BUT NOT REPLICATED. IN ERROR LOG, THE (M-36) ERROR WAS FOUND, CONFIRMING THE FAULT 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 COMPLAINT WAS CONFIRMED BASED ON THE ERROR LOGS BUT THE REPORTED ERROR WAS NOT REPRODUCED BY FAILURE ANALYSIS. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE SYSTEM LOG REPORT WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: A RADICAL PROSTATECTOMY (WITHOUT LYMPHADENECTOMY) PROCEDURE WAS PERFORMED ON (B)(6) 2024 VIA SYSTEM SK5204 BY SURGEON NICO DE GRAEVE. ADDITIONALLY, A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN RPMS QUALITY ENGINEER. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: ERROR 25913 "ERBE ERROR: M-36 - CHECK INSTRUMENT CABLE CONNECTION BETWEEN INSTRUMENT AND ERBE". THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO AN INTERNAL TIMEOUT ERROR IN ERBE GENERATOR AND IT CAN BE RESOLVED BY REPLACING THE ERBE GENERATOR.

    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 AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE INSTRUMENT 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 RADICAL EXTRAPERITONEAL PROSTATECTOMY (WITHOUT LYMPHADENECTOMY) SURGICAL PROCEDURE, THE CUSTOMER'S ERBE GENERATOR WAS NOT RECOGNIZING INSTRUMENTS. THEY HAD TRIED WITH DIFFERENT CAUTERY CABLES AS WELL AS BRAND-NEW CABLES, BUT THE INSTRUMENTS WERE STILL NOT RECOGNIZED. THE TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE USER TO TRY DIFFERENT PORTS, BUT THE ISSUE PERSISTED. AS THE SURGERY WAS ONGOING, THE SURGEON DECIDED TO USE THEIR FORCE TRIAD GENERATOR INSTEAD TO PROCEED WITH THE PROCEDURE. THE USER CONTINUED WITH THE PROCEDURE AS PLANNED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. A PROCEDURE DELAY OF 15 MINUTES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963080 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A 00886874110898

    Patients

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