BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 18244191 · Received December 1, 2023

    Report

    Report Number
    2955842-2023-20768
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    October 17, 2023
    Report Date
    November 2, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874112738
    PMA / PMN Number
    K143132
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT FOR FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE TEFLON PAD DAMAGE UPON VISUAL INSPECTION. THERE APPEARS TO BE THERMAL DAMAGE TO THE TEFLON PAD. A PIECE MEASURING APPROXIMATELY 0.277" X .042" WAS MISSING AND WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER WEDGE RESECTION SURGICAL PROCEDURE, THE WHITE PLASTIC PART OF THE HARMONIC ACE INSTRUMENT TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE INSTRUMENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. THE CUSTOMER INDICATED THAT THE WHITE PART AT THE INSTRUMENT TIP WAS NOT COMPLETELY DETACHED AND NO FRAGMENT FELL INSIDE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504672 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 L82230601 0313 10886874112738

    Patients

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