BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18152346 · Received November 16, 2023

    Report

    Report Number
    2955842-2023-20009
    Event Type
    Injury
    Date Received
    November 16, 2023
    Date of Event
    October 25, 2023
    Report Date
    October 25, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) AND PERFORMED FAILURE ANALYSIS. THE UNIT WAS ANALYZED. THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE UNIT ENERGIZED AND CAUTERIZED ON ALL PORTS AND RECOGNIZED INSTRUMENTS. THE ERROR LOG DID SHOW THAT ERROR M-0B OCCURRED.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE WAS ABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE AND REPLACED THE ERBE GENERATOR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE GENERATOR INVOLVED WITH THIS COMPLAINT; HOWEVER, THE FAILURE ANALYSIS EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS NOT WORKING. THE MONOPOLAR ENERGY WAS WORKING AT FIRST BUT THEN WENT COMPLETELY OUT. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) STATED THAT THE ERBE GENERATOR HAD A MESSAGE STATING THAT THE ENERGY CORD WAS NOT CONNECTED. THE CUSTOMER TRIED A NEW ENERGY CORD AND REBOOTED THE ERBE GENERATOR, BUT THE ISSUE REMAINED. THE CUSTOMER CONVERTED THE PROCEDURE TO OPEN SURGERY. THE CUSTOMER INDICATED THAT THEY DO NOT TRACK THE USES/LIVES OF THE ENERGY CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980858 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-12 N/A

    Patients

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