BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 23931943 · Received December 31, 2025

    Report

    Report Number
    2955842-2025-50220
    Event Type
    Malfunction
    Date Received
    December 31, 2025
    Date of Event
    December 9, 2025
    Report Date
    December 30, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874123454
    PMA / PMN Number
    K241814
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS, AND THE COMPLAINT WAS CONFIRMED. THE SINGLE-PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN INSTRUMENT TUBE ADAPTER. THIS COMPONENT WAS LOCATED AT THE DISTAL END OF THE INSTRUMENT AND SERVES AS THE INTERFACE BETWEEN THE INSTRUMENT AND THE USER INSTALLED TIP ACCESSORY. THE BROKEN PIECE WAS NOT RETURNED AND WOULD HAVE MEASURED APPROXIMATELY 2.49MM X 1.29MM. THE BROKEN TUBE ADAPTER MADE IT DIFFICULT TO INSTALL A TIP AND CAUSED THE TIP TO NOT BE SECURELY ATTACHED. VISUAL INSPECTION WAS PERFORMED AND FOUND NO EXTERNAL DAMAGE TO THE HOUSING. THE HOUSING WAS REMOVED FOR INSPECTION AND FOUND NO INTERNAL DAMAGE. THE INPUT DISKS WERE MANUALLY ARTICULATED WITH NO ISSUES. THE PROBABLE ROOT CAUSE OF A DAMAGED TUBE ADAPTER IS ATTRIBUTED TO EITHER TIP ACCESSORY INSTALLATION ISSUES OR DAMAGE DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SINGLE-PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT GRAY PART OF THE TIP OF THE INSTRUMENT FOR ATTACHING THE MCS CHIP WAS MISSING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE THERMAL DAMAGE WAS IDENTIFIED IN CENTRAL PROCESSING AFTER CLEANING. THE INSTRUMENT WAS INSPECTED FOR DAMAGE PRIOR TO REPROCESSING AND THERE WAS NO DAMAGE OR ANYTHING OUT TO THE ORDINARY OBSERVED. DURING THE PROCEDURE ON (B)(6) 2025, THE INSTRUMENT WAS INSPECTED PRIOR TO USE. IT WAS OBSERVED THAT IT WAS HARD TO ATTACH THE MONOPOLAR CURVED SCISSORS (MCS) TIP. THE INSTRUMENT WAS ALSO INSPECTED AFTER USE AND NOTHING OUT OF THE ORDINARY WAS OBSERVED. IT WAS UNKNOWN IF THERE WERE ANY INSTRUMENT COLLISIONS. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO THE PATIENT. THE PATIENT HAS NOT RETURNED DUE TO ANY POST-SURGICAL COMPLICATION RELATED TO RETENTION OF FOREIGN MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2638699 ENDOWRIST SP MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 430100-02 K10250710 0020 00886874123454

    Patients

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