BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 22778065 · Received August 11, 2025

    Report

    Report Number
    2955842-2025-33611
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    July 9, 2025
    Report Date
    July 14, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119778
    PMA / PMN Number
    K214095
    Removal / Correction Number
    ISIFA2024-09-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) DID RECEIVE THE CADIERE FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE FAILURE ANALYSIS EVALUATION HAS NOT BEEN COMPLETED. .

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CADIERE FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL END.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL GASTRECTOMY SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT WAS NOTED TO BE SHARP. THE SHARPNESS OF THE INSTRUMENT CAUSED INDENTATIONS AND DAMAGE TO THE TISSUE. IT IS UNKNOWN WHAT INTERVENTION WAS REQUIRED TO ADDRESS THE TISSUE INJURY. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034882 ENDOWRIST CADIERE FORCEPS NAY INTUITIVE SURGICAL, INC 471049-08 K14250321 0289 00886874119778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES