BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 18813261 · Received February 29, 2024

    Report

    Report Number
    2955842-2024-11727
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    February 2, 2024
    Report Date
    February 5, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    THE FORCE BIPOLAR INSTRUMENT WAS TRANSFERRED TO THE ADVANCED FAILURE ANALYSIS (AFA) TEAM FOR FURTHER INVESTIGATION. AFA WAS ABLE TO CONFIRM INITIAL FAILURE ANALYSIS FINDINGS. THE INSTRUMENT WAS CONFIRMED TO HAVE A BROKEN MOLDED INSULATOR AND DISLODGED GRIP WHICH WERE NOT RETURNED WITH THE INSTRUMENT. THE MOLDED INSULATOR BREAKING LIKELY CAUSED THE GRIP TO GET DISLODGED ALONG WITH THE MOLDED INSULATOR. THE BROKEN CONDUCTOR WIRE LIKELY OCCURRED IN THIS SAME INSTANCE AS IT WOULD HAVE BEEN CONNECTED TO THE GRIP.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MOLDED INSULATOR AT THE DISTAL END. A PIECE APPROXIMATELY 0.172" X 0.375" IN SIZE WAS MISSING AND NOT RETURNED WITH THE INSTRUMENT. ALSO, THE INSTRUMENT WAS FOUND TO HAVE ONE OF THE GRIP TIPS TO BE DISLODGED. A PIECE APPROXIMATELY 0.183" X 0.598" IN SIZE WAS MISSING AND NOT RETURNED WITH THE INSTRUMENT. THIS FAILURE IS A RESULT OF THE BROKEN MOLDED INSULATOR. THE INSTRUMENT WAS ALSO FOUND TO HAVE A BROKEN CONDUCTOR WIRE. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST. THE WIRE WAS FULLY BROKEN, AND THE CONDUCTOR WIRES WERE EXPOSED. NO SIGNS OF THERMAL DAMAGE WERE OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE JAWS OF THE FORCE BIPOLAR BROKE WHEN GRASPING TISSUE. THE BROKEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE AND THE CASE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED DURING A HYSTERECTOMY, NO TISSUE OR VESSEL WAS DAMAGED, AND THERE WAS NO BLEEDING. THE SURGEON BELIEVED THAT THE EVENT OCCURRED HALFWAY THROUGH THE OPERATION AND WAS NOT CAUSED BY THE DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE EVENT HAD A NON-NEGATIVE EFFECT ON THE PATIENT'S HEALTH, AND THERE WERE NO POST-OPERATIVE COMPLICATIONS. TO COMPLETE THE PROCEDURE, A NEW FORCE BIPOLAR WAS USED AS A REPLACEMENT INSTRUMENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    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
    307073 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10231005 0061 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES