BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 24503015 · Received March 3, 2026

    Report

    Report Number
    2955842-2026-14780
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    January 8, 2026
    Report Date
    March 31, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874113486
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DEVICE FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT ARM DRAPE ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE REPORTED EVENT WITH THE ACCESSORY COULD NOT BE REPLICATED NOR CONFIRMED. THE ACCESSORY WAS INSTALLED IN THE IN-HOUSE SYSTEM AND PASSED RECOGNITION AND ENGAGEMENT WITHOUT ANY ISSUES. ALL FOUR-INSTRUMENT STERILE ADAPTERS WERE SUCCESSFULLY INSTALLED. THE CANNULA STERILE ADAPTER WAS ALSO INSTALLED WITHOUT ISSUE. THE SINGLE PORT (SP) SYSTEM'S DRAPES WERE ALSO SUCCESSFULLY DEPLOYED. THE DRAPE SPIN TEST WAS ALSO PERFORMED AND PASSED. THE INNER AND OUTER LABYRINTH STAYED INTACT AND THERE WAS NO ABNORMAL NOISE OR FRICTION OBSERVED WHEN ROTATING THE INSTRUMENT DROVE 180-DEGREES IN BOTH DIRECTIONS. THE ACCESSORY WAS FULLY FUNCTIONAL. VISUAL INSPECTION WAS CARRIED OUT AND THERE WAS NO DAMAGE FOUND. NO PRODUCT ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE PORT (SP) INSTRUMENT ARM DRAPE WOULD NOT COMBINE AND COULD NOT BE USED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24918 NONE INSTRUMENT ARM DRAPE NAY INTUITIVE SURGICAL, INC 430013-15 1325LA0500 0500 00886874113486

    Patients

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