BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 19610574 · Received June 25, 2024

    Report

    Report Number
    2955842-2024-15843
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    June 3, 2024
    Report Date
    June 3, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116982
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    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 ISSUE AND MADE A CONFIGURATION ADJUSTMENT TO CORRECT REPORTED PROBLEM. THE SYSTEM WAS VERIFIED AND READY TO USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE E-100 GENERATOR DID NOT WORK. THE LED ON POWER BUTTON WAS ON, BUT IT WAS NOT WHILE THE INSTRUMENT WAS CONNECTED. THE CUSTOMER STATED THAT THEY USED THE ERBE GENERATOR WITH THE VESSEL SEALER INSTRUMENT WITHOUT ANY PROBLEM. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) VIEWED THE SYSTEM EVENT LOGS BUT DID NOT NOTICE ANYTHING RELEVANT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE E-100 WAS NOT WORKING AT ALL. IT WAS A NEW DA VINCI SYSTEM INSTALLED. THE CUSTOMER USED THE ERBE GENERATOR AND WERE ABLE TO USE THE VESSEL SEALER WITHOUT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697443 DA VINCI ENERGY E-100 GENERATOR NAY INTUITIVE SURGICAL, INC 378848-07 N/A 00886874116982

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES