BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 24722162 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19686
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    October 22, 2025
    Report Date
    March 27, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    PMA / PMN Number
    K153126
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INSTRUMENT; HOWEVER, INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HASSON CONE BROKE INTO PLASTIC PIECES. IT WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SITE HAD THE SIMILAR FAILURES WITH TOTAL 13 HASSON CONES. IT HAPPENED IN MULTIPLE PROCEDURES ON DIFFERENT DATES. THE REPORTER COULD NOT PROVIDE ANY SPECIFIC TIMELINE ABOUT THE EVENT DATES. SITE RETURNED 5 HASSON CONES. AS PER REPORTER, SOME WERE DISPOSED. SITE DOES NOT KNOW EXACT DISPOSED COUNT. THE FAILURE OCCURRED WHEN THE HASSON CONE WAS ATTACHED TO THE ASSEMBLY. IT BROKE INTO MULTIPLE PIECES. NO FRAGMENT FELL INTO THE PATIENT AND THERE WAS NO PATIENT HARM. THE PROCEDURE WAS COMPLETED BY CHANGING THE CONE ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779640 NONE HASSON CONE GCJ INTUITIVE SURGICAL, INC 470398-05 N/A

    Patients

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