BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14326129 · Received May 7, 2022

    Report

    Report Number
    2955842-2022-11478
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    September 11, 2020
    Report Date
    September 11, 2020
    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
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED ISSUE OF ¿BOTH MONOPOLAR AND BIPOLAR ENERGY STOPPED WORKING¿ WAS UNABLE TO BE DETERMINED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. FAILURE ANALYSIS INVESTIGATION COULD NOT BE PERFORMED, AS NO INSTRUMENTS FROM THIS EVENT WAS RETURNED FOR EVALUATION. ALSO, NO IMAGE OR VIDEO CLIP OF THE REPORTED EVENT WAS PROVIDED TO ISI FOR REVIEW. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM EVENT LOGS AND FOUND ERRORS 25913 (M-35) AND 25920 INDICATING THE SYSTEM REQUESTED ACTIVATION OF A NON-MOUNTED DA VINCI INSTRUMENT AND ACTIVATION HALTED BY EXTERNAL EQUIPMENT ON MONOPOLAR AND BIPOLAR PORT 2. AN ISI FIELD SERVICE ENGINEER (FSE) WAS THEN DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED INCIDENT. IN THIS CASE, THIS REPORTED COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION. DURING SYSTEM TESTING, ENERGY WAS AVAILABLE THE ENTIRE TIME WITH FSE INSTRUMENTS AND CABLES. THE FSE WAS INFORMED THAT THE ENERGY CABLES USED DURING THE CASE WERE GRAY INSTEAD OF YELLOW/BLUE. THE FSE SUSPECTED THAT THE ISSUE WAS LIKELY DUE TO FAULTY ENERGY ACTIVATION CABLES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, BOTH MONOPOLAR AND BIPOLAR ENERGY ALLEGEDLY STOPPED WORKING. THE PROCEDURE WAS THEN CONVERTED TO LAPAROSCOPIC, AND THE SURGERY WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. AT THIS TIME, AVAILABLE INFORMATION INDICATED THAT THE CAUSE OF THE REPORTED ISSUE REMAINS UNCLEAR. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, BOTH MONOPOLAR AND BIPOLAR ENERGY ALLEGEDLY STOPPED WORKING. PRIOR TO CONTACTING INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT, THE CALLER STATED THAT THEY SWAPPED ENERGY CORDS AND INSTRUMENTS, BUT THE ISSUE PERSISTED. THE CALLER STATED THAT THEY THEN POWER CYCLED THE GENERATOR, BUT THE ISSUE REMAINED. AN ISI TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM EVENT LOGS AND FOUND ERRORS 25913 (M-35) AND 25920 INDICATING THE SYSTEM REQUESTED ACTIVATION OF A NON-MOUNTED DA VINCI INSTRUMENT AND ACTIVATION HALTED BY EXTERNAL EQUIPMENT ON MONOPOLAR AND BIPOLAR PORT 2. THE TSE ASKED THE CALLER IF THEY TRIED PORT 1 OF BOTH ENERGY TYPES. THE CALLER STATED THAT THEY ALSO TRIED THAT BUT THE ISSUE REMAINED UNRESOLVED. THE TSE THEN ASKED THE CALLER IF THEY HAD ANY EXTERNAL ENERGY EQUIPMENT THAT COULD HAVE CAUSED THE ISSUE; THE CALLER STATED "NO." THE TSE THEN ASKED CALLER IF THEY KEPT TRACK OF THE INSTRUMENT ENERGY CORDS; THE CALLER STATED THAT THEY DID. THE CALLER WAS NOT ABLE TO TROUBLESHOOT FURTHER AS THE SURGEON ELECTED TO CONVERT TO TRADITIONAL LAPAROSCOPIC SURGERY. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351728 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 Female DA VINCI INSTRUMENTS AND ACCESSORIES