BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 18860349 · Received March 7, 2024

    Report

    Report Number
    2955842-2024-12156
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    February 13, 2024
    Report Date
    February 13, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115343
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTEGRATED ELECTROSURGICAL UNIT (IESU) HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM. THE IESU WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE REPORTED FAILURE OF ERROR C-34 WAS CONFIRMED AND REPRODUCED ON START-UP WITH THE MONOPOLAR ENERGY.

    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 ISI FSE REPLACED THE INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) DUE TO THE C-34 ERROR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE PART; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) WAS GIVING AN ERROR C-34 WHEN ATTEMPTING TO FIRE MONOPOLAR ENERGY. PRIOR TO CALLING ISI TECHNICAL SUPPORT, THE CUSTOMER HAD REPLACED THE MONOPOLAR INSTRUMENT CABLE ALONG WITH THE INSTRUMENT, RESTARTED THE IESU, AND TRIED THE SECOND MONOPOLAR PORT WITHOUT SUCCESS. THE ISI TSE VIEWED THE SYSTEM EVENT LOGS AND NOTICED SEVERAL ERRORS AS C-34 AND M11 INDICATING AN ISSUE WITH THE IESU. THE ISI TSE CONFIRMED THAT THERE WERE NO DEVICES SUSCEPTIBLE TO PRODUCING ELECTROMAGNETIC INTERFERENCES SUCH AS COMPUTERIZED TOMOGRAPHY (CT) SCANS OR OTHER GENERATORS. ACCORDING TO THE NURSE, THE IESU WAS DIRECTLY CONNECTED TO A DEDICATED ALTERNATING CURRENT (AC) PLUG, AND THE CABLES IN THE BACK SIDE OF THE IESU SEEMED TO BE PROPERLY CONNECTED. THE ISI TSE ASKED HER TO POWER OFF THE IESU AND UNPLUG ITS POWER CORD FOR 30 SECONDS; THE ERROR PERSISTED. THE ISI TSE ASKED IF THE CUSTOMER HAD A FORCETRIAD GENERATOR AND THE RELATED CABLE ALLOWING THEM TO USE IT WITH THE SYSTEM, BUT THE CUSTOMER DID NOT HAVE A THIRD-PARTY GENERATOR. THE NURSE EXPLAINED THAT THE SURGEON WAS GOING TO PROCEED LAPAROSCOPICALLY. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745929 DA VINCI XI VISION SIDE SYSTEM, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380721-07 N/A 00886874115343

    Patients

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