BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19899548 · Received August 2, 2024

    Report

    Report Number
    2955842-2024-17792
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    June 4, 2024
    Report Date
    July 9, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS AND THE COMPLAINT WAS CONFIRMED. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE CHARRING AND LOCALIZED MELTING ON THE BIPOLAR YAW PULLEY AT THE BASE OF THE GRIP. AS A RESULT OF THE DAMAGE, SECTION OF THE ACTIVE ELECTRODE (GRIP) IS EXPOSED THAT WOULD NOT NORMALLY BE EXPOSED. THE INSTRUMENT GRIPS WERE MANUALLY MANIPULATED, AND THE INSTRUMENT PASSED AN ELECTRICAL CONTINUITY TEST ON 3 OUT OF 3 ATTEMPTS. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT DELIVERED ENERGY WITH SIGNS OF ARCING ON 3 OF 3 ATTEMPT. A REVIEW OF THE PROCEDURE LOGS INDICATED THAT A MONOPOLAR INSTRUMENT WAS USED DURING THIS CASE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SALPINGO-OOPHORECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS OBSERVED TO HAVE A BURN MARK ON THE PLASTIC HOUSING AROUND THE TIPS. AS A RESULT, THE CUSTOMER WAS AFRAID THE INSTRUMENT COULD ARC AND CAUSED AN UNKNOWN DAMAGE. NO FRAGMENT FELL INSIDE THE PATIENT. 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 CUSTOMER CONFIRMED THAT THE THERMAL DAMAGE TO THE INSTRUMENT WAS FIRST OBSERVED DURING PROCEDURE. HOWEVER, THERE WAS NO REPORT OF ARCING OR THE INSTRUMENT COLLIDING WITH AN ENERGY INSTRUMENT DURING THE PROCEDURE. IT WAS UNKNOWN WHAT THE SURGEON BELIEVES TO HAVE CAUSED THE THERMAL DAMAGE TO THE INSTRUMENT, BUT THE CUSTOMER DID NOT WANT TO TAKE ANY CHANCES, AND THEREFORE, THE INSTRUMENT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383640 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K12240222 0171

    Patients

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