BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 18214679 · Received November 28, 2023

    Report

    Report Number
    2955842-2023-20601
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    October 25, 2023
    Report Date
    October 31, 2023
    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
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SYNCHROSEAL WAS ANALYZED AND FOUND TO HAVE A TORN JAW COVER. THE TEARS MEASURED APPROXIMATELY 0.031" - 0.036" IN LENGTH. NO MATERIAL APPEARS TO BE MISSING. THE INSTRUMENT PASSED THE RECOGNITION, ENGAGEMENT, SELF-CHECK TESTS AND MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. UPON VISUAL INSPECTION, ALL 9 JAW CERAMIC DOTS WERE PRESENT AT THE TIPS. THE ENERGY CORD WAS RETURNED CUT, SO ENERGY DELIVERY WAS UNABLE TO BE PERFORMED. ADDITIONALLY, VISUAL INSPECTION WAS PERFORMED, AND THE INSTRUMENT WAS FOUND TO HAVE A DAMAGED CUT ELECTRODE. A TORN CUT ELECTRODE WAS OBSERVED. THE INSTRUMENT WAS FOUND TO HAVE SCRATCH MARKS/ABRASIONS ON THE GRIP TIP. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    ADVANCED FAILURE ANALYSIS (AFA) CONFIRMED THE INITIAL FINDINGS OF DAMAGED JAW COVER AND EXPOSED ELECTRODE. THE INSTRUMENT WAS USED FOR 42 MINUTES DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    BASED ON ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THE INSTRUMENT INVOLVED WITH THIS COMPLAINT DOES NOT MEET THE CRITERIA FOR FIELD ACTION# ISIFA2022-01-C, AS PREVIOUSLY LISTED IN SECTION H9.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THERE WAS A HOLE IN THE PROTECTIVE COVER/RUBBER PART OF THE SYNCHROSEAL. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM AND NO DELAYS. INTUITIVE SURGICAL (IS) CONTACTED THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE CUSTOMER STATES THE SYNCHROSEAL WAS REMOVED FROM THE SEALED PACKAGING ALREADY DEFECTIVE. THE INSTRUMENT WAS REMOVED FROM THE OPERATING TABLE AND WAS NOT USED ON THE PATIENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554090 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-06 L15230608 0151 10886874117306

    Patients

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