BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16465578 · Received March 2, 2023

    Report

    Report Number
    2955842-2023-11012
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    February 3, 2023
    Report Date
    February 3, 2023
    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
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE BIPOLAR FUNCTION WAS STILL WORKING AFTER THE SURGEON RELEASED THE FOOT PEDAL, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER CHANGE THE ENERGY SETTING ON THE EXTERNAL FORCE TRIAD GENERATOR AND POWER CYCLE THE SYSTEM TO RESOLVE THE REPORTED PROBLEM. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE BIPOLAR FUNCTION WAS STILL WORKING AFTER THE SURGEON RELEASED THE FOOT PEDAL. THE ALLEGATION COULD BE RELATED TO THE POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO REPORT THAT THE BIPOLAR FUNCTION WAS STILL WORKING AFTER THE SURGEON RELEASED THE FOOT PEDAL. SYSTEM FUNCTIONALITY WAS REPORTEDLY CHECKED PRIOR TO USE, AND NO ISSUES/ERRORS WERE NOTED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER CHANGE THE ENERGY SETTING ON THE EXTERNAL FORCE TRIAD GENERATOR AND POWER CYCLE THE SYSTEM TO RESOLVE THE REPORTED PROBLEM. THE SITE CONTINUED WITH THE PROCEDURE AS PLANNED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON WAS USING AN UNSPECIFIED BIPOLAR INSTRUMENT WITH AN EXTERNAL FORCE TRIAD GENERATOR AT THE TIME OF THE EVENT. THE SURGEON RELEASED THE FOOT PEDAL AT THE SURGEON SIDE CONSOLE (SSC), BUT THE BIPOLAR ENERGY ACTIVATION WAS STILL WORKING. THE SURGEON NOTED THAT THE ISSUE MIGHT BE RELATED TO THE SSC FOOT PEDAL OR FORCE TRIAD GENERATOR. THE SITE ADJUSTED THE AUTO-FIRE SETTING AND COMPLETED THE PROCEDURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515617 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-61 N/A 00886874110898

    Patients

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