BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17140753 · Received June 15, 2023

    Report

    Report Number
    2955842-2023-16366
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 23, 2023
    Report Date
    May 23, 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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS COULD NOT REPRODUCE THE REPORTED ISSUE. THE IESU WAS ABLE TO ENERGIZE AND CAUTERIZE NORMALLY. ALL PORTS RECOGNIZED INSTRUMENTS. NO PROBLEM WAS FOUND.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING, THE INTEGRATED ELECTROSURGICAL UNIT (IESU) DID NOT RECOGNIZE BIPOLAR INSTRUMENTS. AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. BASED ON THE FIELD EVALUATION, THE FSE CONFIRMED, THAT THE VIO DV IESU DID NOT RECOGNIZED BOTH MONOPOLAR AND BIPOLAR INSTRUMENTS. THE FSE THEN REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER. AND THAT THE IESU UNIT HAS BEEN RECEIVED FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED POST FAILURE ANALYSIS EVALUATION AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    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 DISTAL GASTRECTOMY SURGICAL PROCEDURE. THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE), THAT THE INTEGRATED ELECTROSURGICAL UNIT (IESU) DID NOT RECOGNIZE BIPOLAR INSTRUMENTS. THE CUSTOMER REPLACED THE BIPOLAR CABLES AND POWER CYCLED VIO DV IESU, BUT THE ISSUE PERSISTED. THE TSE DID NOT FIND ANY RELATED ERROR IN THE LOGS. THE TSE HAD THE CUSTOMER REPLACED THE INSTRUMENT AND THE ENERGY CABLE AGAIN, BUT VIO DV IESU COULD ONLY RECOGNIZE ENERGY INSTRUMENTS INTERMITTENTLY AFTER THE REPLACEMENTS. THE TSE ADVISED THE CUSTOMER TO USE EXTERNAL GENERATORS TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM, AND VIO DV IESU INITIALLY POWERED ON WITHOUT ERRORS. HOWEVER, ¿DV?¿ ICON APPEARED ON THE RIGHT SIDE OF VIO DV IESU WHEN IT WAS USED. THE CUSTOMER WAS NOT ABLE TO CONTINUE TO USE VIO DV IESU DURING THE PROCEDURE. THE ISSUE WAS RESOLVED BY USING THE EXTERNAL GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188034 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-24 N/A 00886874110898

    Patients

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