BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 22857783 · Received August 21, 2025

    Report

    Report Number
    2955842-2025-34975
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 31, 2025
    Report Date
    July 31, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114285
    PMA / PMN Number
    K182371
    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) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SINGLE PORT (SP) 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 MEASURES APPROXIMATELY 3.40 MM X 2.19 MM IN SIZE. THE COMPLAINT REGARDING THE GRAY PLASTIC TIP WHERE MCS TIP WOULD BE SCREWED ON WAS BROKEN WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THE BROKEN TUBE ADAPTER AND THE DETACHED FRAGMENT FROM THE TUBE ADAPTER IS ATTRIBUTED TO EITHER TIP ACCESSORY INSTALLATION ISSUES OR DAMAGE DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN OPENING THE TRAY THAT THE INSTRUMENT WAS STERILIZED IN, THE GRAY PLASTIC TIP OF THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS FOUND TO BE BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND WAS ADVISED THAT THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO THE PATIENT WHEN THE INSTRUMENT WAS LAST USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2053527 ENDOWRIST SP MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 430004-62 K11250313 0003 00886874114285

    Patients

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