BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 23639269 · Received November 24, 2025

    Report

    Report Number
    2955842-2025-46177
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 24, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874124048
    PMA / PMN Number
    K241814
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN INSTRUMENT TUBE ADAPTER. THIS COMPONENT IS 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 5.14MM X 4.46MM IN SIZE. THE BROKEN TIP ADAPTER MADE IT DIFFICULT TO INSTALL A TIP AND CAUSED THE TIP TO NOT BE SECURELY ATTACHED. A VISUAL INSPECTION WAS PERFORMED AND FOUND NO EXTERNAL DAMAGE TO THE SHAFT. THE HOUSING WAS REMOVED FOR INSPECTION AND FOUND NO DAMAGE WITHIN THE INSTRUMENT'S HOUSING. INPUT DISKS ARTICULATED WITH NO ISSUES. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. 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 PRIOR TO THE START OF A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT'S TIP WAS BROKEN, AND THE SCISSOR COULD NOT BE PLACED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TIP WAS NOTICED BEFORE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308467 ENDOWRIST SP MONOPOLAR CURVED SCISSORS ER NAY INTUITIVE SURGICAL, INC 431100-01 K12250110 0019 00886874124048

    Patients

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