BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 18718150 · Received February 15, 2024

    Report

    Report Number
    2955842-2024-11263
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 22, 2024
    Report Date
    January 22, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    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

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT AND REPLACED THE E-100 GENERATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PRODUCT INVOLVED WITH THIS COMPLAINT HAS BEEN RECEIVED, BUT ANALYSIS HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED E-100 GENERATOR INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS COULD NOT REPLICATE THE REPORTED COMPLAINT. THIS GENERATOR WAS INSTALLED ONTO THE TEST SYSTEM, AND IT WORKED NORMALLY WITH AN IN-HOUSE VESSEL SEAL INSTRUMENT WITHOUT ANY ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY SURGICAL PROCEDURE, THE POWER BUTTON LED ON THE E-100 GENERATOR WAS NOT LIT WHEN PRESSING IT. THE CUSTOMER COULD HEAR THE FAN SOUND OF THE GENERATOR. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). THE TSE DID NOT FIND ANY RELATED ERROR IN THE LOGS. THE TSE ADVISED THE CUSTOMER TO SEAT THE ENERGY CABLE AND INSTRUMENT AND TO USE THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) IF NECESSARY. 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. THE E-100 GENERATOR DID NOT INITIALLY POWER ON WITHOUT ERRORS. THE CUSTOMER WAS NOT ABLE TO CONTINUE TO USE THE E-100 GENERATOR. THE ISSUE WAS RESOLVED BY USING THE ERBE IESU.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379164 DA VINCI ENERGY E-100 GENERATOR NAY INTUITIVE SURGICAL, INC 374848-09 N/A

    Patients

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