BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 24476721 · Received February 27, 2026

    Report

    Report Number
    2955842-2026-14640
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    January 30, 2026
    Report Date
    April 30, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    PMA / PMN Number
    K221591
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE FSE SPOKE WITH CUSTOMER ABOUT LEAVING THE LIGHT GUIDE ATTACHED TO CAMERA TO ALLOW FOR COOLING. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE THE PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE FIELD EVALUATION RESULTS. THE REPORTED ISSUE COULD NOT BE REPRODUCED BY THE FIELD SERVICE ENGINEER, AND REVIEW OF THE SYSTEM LOGS DID NOT PROVIDE SUFFICIENT INFORMATION TO ESTABLISH A DEFINITIVE ROOT CAUSE. A RISK ITEM CANNOT BE ADDED TO THIS EVENT SINCE INTUITIVE IS CONSIDERED TO BE A DISTRIBUTOR OF THIS MEDICAL DEVICE. SCHOLLY FIBEROPTIC GMBH IS THE MANUFACTURER OF THIS MEDICAL DEVICE AND OWNS THE RISK MANAGEMENT FILE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FIELD ENGINEER CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THE SCHOLLY LIGHT GUIDE BECAME TOO HOT. 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 INITIAL REPORTER CONFIRMED THAT THE ISSUE WAS NOTED DURING PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WERE NO INJURY OR HARM TO THE PATIENT AND STAFF. THE CUSTOMER CONTINUED USING THE SAME HANDHELD CAMERA. THE HOLE WAS NOTED ON THE DRAPE. THE DRAPE WAS NOT CHANGED. THE CUSTOMER WAS GUIDED TO RMA THE CAMERA IF NEEDED. THE PROCEDURE WAS COMPLETED USING SAME CAMERA.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531741 NONE NIR HANDHELD CAMERA GCJ INTUITIVE SURGICAL, INC 470655-01 N/A

    Patients

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