BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20038084 · Received August 22, 2024

    Report

    Report Number
    2955842-2024-18410
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 24, 2024
    Report Date
    July 24, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SITE VISIT WAS PERFORMED AND AFTER ELECTRICAL TESTING ON THE ERBE, THERE WAS NO TROUBLE FOUND. THE FENESTRATED BIPOLAR FORCEPS (FBF) WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) AND FAILURE ANALYSIS (FA) FOUND CHARRING AND LOCALIZED MELTING ON BIPOLAR YAW PULLEY, NEAR THE GRIP. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THOUGH NOT DIRECTLY IMPLICATED IN THE REPORTED EVENT, THE MONOPOLAR CURVED SCISSORS (MCS) USED IN THE PROCEDURE WAS RETURNED TO ISI AND FA COULD NOT REPLICATE OR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THERE WAS NO DAMAGE OR PRODUCT ISSUE IDENTIFIED. THE INSTRUMENT WAS TESTED IN-HOUSE AND MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE GRIPS OPENED AND CLOSED PROPERLY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT WAS OBTAINED. THERE WERE NO SYSTEM LOG ERRORS THAT WERE RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN REMOVING THE CANNULAS AFTER A DA VINCI ASSISTED HYSTERECTOMY, THE STAFF NOTICED THE PATIENT WAS BURNED. THE BURN WAS NOTED IN THE AREA THAT WOULD HAVE BEEN USING THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. DURING FOLLOW UP WITH THE ROBOTICS COORDINATOR (ROCO), IT WAS STATED THE SURGEON DENIED THE OCCURRENCE OF ARCING. THE SURGEON DIDN'T CLASSIFY THE BURN, BUT DESCRIBED IT AS BEING A VERY SUPERFICIAL, REDDENED, CIRCUMFERENTIAL BURN (AROUND THE CANNULA) AT THE PORT SITE OF THE FBF. ALSO, IT WAS STATED THE SURGEON DIDN¿T USE ANY CAUTERY ON THE BIPOLAR AND THERE WAS NO DOUBLE CANNULATION.

    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
    24054 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K14240411 0469 00886874119808

    Patients

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