BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 22307723 · Received June 23, 2025

    Report

    Report Number
    2955842-2025-26326
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    May 29, 2025
    Report Date
    May 29, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. SECTION A ADDITIONAL INFORMATION: HEIGHT: 182.88 CM. BODY MASS INDEX (BMI): 29.9 KG/M2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY, THE TIP OF THE PERMANENT CAUTERY HOOK INSTRUMENT BROKE AND FELL INTO THE PATIENT DURING THE TASK OF DISSECTING. THE SURGEON DOES NOT KNOW THE CAUSE OF THE ISSUE. THE FRAGMENT WAS RETRIEVED WITH A GRASPER. IT WAS CONFIRMED THAT ALL PIECES WERE RETRIEVED BY PIECING THE PART THAT BROKE TO THE HOOK AND IT FIT PROPERLY. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS, SUCH AS AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACK-UP PERMANENT CAUTERY HOOK. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THERE WAS NO INJURY TO THE PATIENT. THE BROKEN TIP WAS DISPOSED OF, BUT THE INSTRUMENT IS AVAILABLE FOR RETURN TO ISI. THE CUSTOMER HAS NOT REQUESTED AN RMA AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927942 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-18 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES