BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 19094093 · Received April 11, 2024

    Report

    Report Number
    2955842-2024-13409
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    January 18, 2024
    Report Date
    March 12, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 8MM SYNCHROSEAL INSTRUMENT WAS ANALYZED AND FOUND THE PRIMARY FAILURE OF IMPRECISE MOTION TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND EXHIBITED IMPRECISE MOTION. THE GRIP TIPS WOULD NOT FULLY CLOSE. NO LOOSE GRIP CABLE OR OBVIOUS SIGNS OF DAMAGE WERE FOUND. THERE WERE NO CERAMIC DOTS MISSING, AND A REVIEW OF THE LOGS SHOWED NO ERRORS. THE INSTRUMENT WAS TRANSFERRED TO ADVANCED FAILURE ANALYSIS (AFA) FOR FURTHER INVESTIGATION. AFA CONFIRMED THE INITIAL FA FINDING THAT THE GRIP WOULD NOT CLOSE. THE JAW COVER WAS REMOVED, AND IT WAS NOTED THAT THE DISTAL PIN THAT GOES INTO THE CRIMPED FITTING WAS BROKEN IN HALF. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE 8MM SYNCHROSEAL INSTRUMENT ASSOCIATED WITH THE CUSTOMER-REPORTED COMPLAINT. THE INSTRUMENT WAS ANALYZED AND EXHIBITED IMPRECISE MOTION, AND THE GRIPS WOULD NOT FULLY CLOSE. THE JAW COVER WAS REMOVED, AND IT WAS NOT THAT THE DISTAL PIN THAT GOES INTO THE CRIMPED FITTING WAS BROKEN IN HALF. A REVIEW OF THE LOGS SHOWED THAT THE INSTRUMENT WAS USED FOR ABOUT 1 HOUR, 48 MINUTES. QTY (B)(4) COAG EVENTS WITH NO ERRORS, QTY (B)(4) SEAL EVENTS WITH 15 HIGH INITIAL STARTING IMPEDANCE ERRORS AND QTY 113 TRANSECT EVENTS WITH 2 HIGH INITIAL STARTING IMPEDANCE ERRORS WERE OBSERVED. THE INSTRUMENT WAS USED FOR A CONSIDERABLY LONG PERIOD OF TIME.

    Additional Manufacturer Narrative · 0

    REFER TO THE CORRECTED ANNEX D CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM SYNCHROSEAL INSTRUMENT JAWS WOULD NOT CLOSE. THE SURGEON HAD TO USE ANOTHER INSTRUMENT TO CLOSE THE JAWS TO REMOVE THE INSTRUMENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    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
    778574 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-06 L10230817 0078 10886874117306

    Patients

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