BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17131135 · Received June 14, 2023

    Report

    Report Number
    2955842-2023-16326
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    February 27, 2023
    Report Date
    May 16, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119785
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE INSTRUMENT COULD NOT BE REMOVED FROM THE TROCAR, 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 PROGRASP FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MAIN TUBE. A PIECE MEASURING APPROXIMATELY 0.150" X 0.229 WAS NOT RETURNED WITH THE INSTRUMENT. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE CLAMPING PULLEY CABLE GROOVES WERE FOUND TO HAVE EXCESSIVE AMOUNT OF DRIED RESIDUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE THAT PROGRASP FORCEPS INSTRUMENT WAS UNABLE TO BE REMOVED FROM THE TROCAR. THE SURGEON ENDED UP REMOVING THE TROCAR WITH THE PROGRASP FORCEPS STILL INSERTED, AS THE TROCAR AND INSTRUMENT COULD NOT BE SEPARATED. THE INSTRUMENT WAS SENT TO STERILE PROCESSING STILL IN THE TROCAR TO BE SEPARATED. THE CONDITION OF THE INSTRUMENT WAS COMPLETELY INTACT PRIOR TO BEING SENT TO STERILE PROCESSING; IT APPEARS THAT THE FORCE REQUIRED TO REMOVE THE INSTRUMENT FROM THE TROCAR CAUSED SIGNIFICANT DAMAGE TO THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. ON (B)(6) 2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5115723 STATING: "DURING A ROBOTIC CHOLE, THE PROGRASP WAS UNABLE TO BE REMOVED FROM THE ROBOTIC TROCAR. THE SURGEON ENDED UP REMOVING THE TROCAR WITH THE PROGRASP STILL INSERTED AS THE TROCAR AND INSTRUMENT COULD NOT BE SEPARATED. THE PROGRASP WAS SENT DOWN TO SPD STILL IN THE TROCAR FOR SPD TO SEPARATE THEM. THERE WERE NO DEVIATIONS IN CARE AND NO HARM TO PATIENT CAUSED, AND THE PROCEDURE WAS COMPLETED AS PLANNED." INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER NOTED NO FRAGMENTS FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874570 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-11 K11220614 0145 00886874119785

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES