BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17209608 · Received June 27, 2023

    Report

    Report Number
    2955842-2023-16643
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    May 31, 2023
    Report Date
    June 1, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING DIFFICULT TO REMOVE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND REPORTED FAILURE WAS NEITHER REPLICATED NOR CONFIRMED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS IDENTIFIED. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE: SIGNS OF CORROSION WERE FOUND ON THE INSTRUMENT BEARINGS. PITCH AND GRIP INPUT DISK BEARINGS EXHIBIT ORANGE DISCOLORATION. THE COMPLAINT REGARDING DIFFICULT TO REMOVE WAS NOT CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THE SURGICAL PROCEDURE, THE FORCE BIPOLAR WAS DIFFICULT TO REMOVE FROM THE PATIENT AND THE METAL PIECE KEPT POPPING OUT. 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 INSTRUMENT WAS INSPECTED BEFORE INSERTING INTO THE PATIENT. NO DAMAGE NOTED ON FORCE BIPOLAR. THE INSTRUMENT AND CANNULA WERE REMOVED TOGETHER THE FIRST TIME IT HAPPENED BECAUSE THE END OF THE FORCE THAT ATTACHES THE TIP TO THE HANDLE WAS OUT AND KEPT GETTING HOOKED ON THE END OF THE CANNULA. THE SURGEON ATTEMPTED TO STRAIGHTENED THE TIP OUT SO THE HOOK WOULD BE INSIDE THE HANDLE PART BUT THE HOOK WOULD NOT GO BACK IN. CAREFULLY THEY WERE ABLE TO REMOVE BOTH CANNULA AND INSTRUMENT WITHOUT CAUSING ANY DAMAGE TO THE INSERTION SITE. THE SECOND AND SUBSEQUENT TIMES IT HAPPENED THE SURGEON WAS ABLE TO MAINTAINED THE TIP WITH THE HOOK INSIDE THE HANDLE AND THE INSTRUMENT WAS REMOVED FROM THE CANNULA WITH NO PROBLEMS, THE PORT INCISION WAS NOT EXTENDED, THE ONLY THING THAT WAS NOTICED WAS THAT THE PIN WOULD LOOK LIKE A HOOK WHICH WOULD NOT ALLOW THE INSTRUMENT TO GO INTO THE CANNULA WITHOUT IT BEING HELD STRAIGHT, THE SURGEON WAS USING THE FORCE BIPOLAR TO CAUTERIZE THE TISSUE, THERE WAS NO COLLISION WITH OTHER INSTRUMENTS DURING THE CASE. THE SURGEON WAS ONLY USING THE FORCE BIPOLAR AND THE MONOPOLAR SCISSORS, THE INSTRUMENTS JAWS WERE NOT STUCK IN THE CLOSE POSITION. THE SURGEON COMPLAINED THAT IT WAS MOVING PROPERLY. NO FRAGMENTS OF THE FORCE BIPOLAR FELL INTO THE PATIENT AS FAR AS THEY SAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220553 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K11210906 0112 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES