BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 23150961 · Received September 25, 2025

    Report

    Report Number
    2955842-2025-39361
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    September 9, 2025
    Report Date
    December 11, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 SINGLE PORT MONOPOLAR CURVED SCISSORS (MCS) 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 MEASURED APPROXIMATELY 1.20MM X 2.15MM IN SIZE. THE INSTRUMENT WAS FOUND TO HAVE A DETACHED FRAGMENT. THE DETACHED FRAGMENT BROKE OFF FROM THE INSTRUMENTS TUBE ADAPTER. THE INSTRUMENT WAS INSPECTED AND FOUND TO HAVE NO DAMAGE ON THE DRIVE ROD COUPLING. THE INSTRUMENT WAS RETURNED WITHOUT THE MCS TIP ACCESSORY. AN IN-HOUSE MCS TIP WAS INSTALLED ON THE INSTRUMENT/SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TEST. THE INSTRUMENT TIPS OPENED/CLOSED PROPERLY 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE SINGLE PORT MONOPOLAR CURVED SCISSORS INSTRUMENT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MONOPOLAR CURVED SCISSORS SP INSTRUMENT WOULD NOT CLOSE OR OPEN. THE CUSTOMER VISUALLY INSPECTED THE INSTRUMENT AND FOUND THAT THE TIP WAS MISSING. THE INSTRUMENT WAS NOT USED ON THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299394 ENDOWRIST SP MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 430004-62 K10250320 0008

    Patients

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