BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 24193568 · Received January 27, 2026

    Report

    Report Number
    2955842-2026-01692
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    December 30, 2025
    Report Date
    January 27, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER, AND IT WAS CONFIRMED THAT THERE WERE NO ISSUES WITH THE SYSTEM. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. ISI DID NOT RECEIVE A PRODUCT FOR FAILURE ANALYSIS EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE STAFF CALLED TO REPORT AN ISSUE. A SUTURE HAD BEEN LOST INSIDE THE PATIENT, AND THE SURGEON BELIEVED THERE WAS SOME TYPE OF ENDOSCOPE FUNCTION THAT WOULD ALLOW THEM TO INCREASE VISUALIZATION TO FIND THE SUTURE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE LOGS AND FOUND NO RELATED ISSUE. THE TSE EXPLAINED THERE WERE SOME FEATURES IN THE ENDOSCOPE THAT COULD BE UTILIZED LIKE THE DIGITAL ZOOM FUNCTION AND ADVISED THE STAFF COULD PUT THE ENDOSCOPE INTO ANY ARM ON THE SYSTEM TO HELP SEARCH FOR THE SUTURE. THE CUSTOMER STATED THE SURGEON DID NOT WANT TO MOVE THE ENDOSCOPE TO ANOTHER PORT. THE CUSTOMER STATED THEY WERE BRINGING IN AN X-RAY DEVICE TO HELP LOOK FOR THE SUTURE AND THE CALL ENDED. THE PROCEDURE WAS COMPLETED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NEEDLE DRIVER WAS FUNCTIONING PROPERLY. THE FRAGMENT WAS FOUND AND RETRIEVED. X-RAY WAS NOT UTILIZED. THERE WAS NO NOTED INJURY TO PATIENT. THE PROCEDURE WAS COMPLETED AS USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257735 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-17 K12250206 0126 00886874119815

    Patients

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