BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 21930795 · Received April 29, 2025

    Report

    Report Number
    2955842-2025-17044
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 1, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874114374
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MCS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND THE MCS RETAINING TIP WAS FOUND TO HAVE A CRACKING DAMAGE. NO MATERIAL APPEARS TO BE MISSING. THIS DAMAGE IS TYPICALLY OBSERVED DURING ACCESSORY INSTALLATION WHEN THE RETAINING TIP COVER IS PUSHED OVER THE INSTRUMENT TUBE ADAPTER WITHOUT BEING CORRECTLY ALIGNED, IF THE RETAINING COVER IS TWISTED BEFORE THE ACCESSORY IS FULLY SEATED, OR IF THE RETAINING COVER IS OVER-ROTATED. IF THE RETAINING COVER IS INCORRECTLY ALIGNED AND THE BAYONET DOES NOT ENTER THROUGH THE RETAINING CHANNEL ON THE INSTRUMENT TUBE ADAPTER, THE BAYONETS IN THE RETAINING COVER CAN BE FORCED OUTWARDS AND RESULT IN THE DAMAGE OBSERVED. PROPER ALIGNMENT IS ACHIEVED BY LINING UP THE WHITE STRIPE ON THE INSTRUMENT WITH THE BLACK STRIPE ON THE COVER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP INSTALLED ON AN MCS INSTRUMENT, CAME OFF AND FELL INSIDE THE PATIENT'S BODY. THE CUSTOMER RETRIEVED THE MCS TIP AND TRIED TO PUT IT BACK ON THE MCS INSTRUMENT; HOWEVER, IT DID NOT WORK FOR AN UNSPECIFIED REASON. THEREFORE, THE CUSTOMER REPLACED THE MCS TIP. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE AND NOTHING ABNORMAL WAS NOTED. IT IS UNKNOWN WHAT TASK WAS BE BEING PERFORMED AT THE TIME OF THE EVENT. THE SURGEON STATED THAT THE TIP OF THE MCS INSTRUMENT HAD BECOME STUCK IN THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT AND THEN IT WAS FORCIBLY REMOVED, WHICH WAS THE CAUSE OF THE MCS TIP INSIDE THE PATIENT. IT IS UNKNOWN FOR HOW LONG THE INSTRUMENT WAS IN USE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT PRIOR TO THE VENT. THE SURGEON DID NOT FEEL ANY RESISTANCE UPON FINAL REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. ADDITIONALLY, THE SURGICAL STAFF DID NOT SEE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. IT IS UNKNOWN IF SURGICAL STAFF NOTICED ANY DAMAGE TO THE INSTRUMENT AFTER THE EVENT. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE MCS TIP. IT IS UNKNOWN IF ANY POST OPERATIVE TEST LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. THERE ARE NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS AVAILABLE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223583 DA VINCI MONOPOLAR CURVED SCISSORS (MCS) TIP NAY INTUITIVE SURGICAL, INC 430035-13 K10241017 10886874114374

    Patients

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