BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCHOELLY CAMERA

    MDR report key: 23544510 · Received November 13, 2025

    Report

    Report Number
    2955842-2025-44637
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 13, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) SPOKE WITH THE SITE'S ROBOTICS COORDINATOR, WHO ATTRIBUTED THE MATTER TO USER ERROR AND REPORTED NO IDENTIFIED PROBLEMS. THE FSE COULD NOT REPRODUCE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED READY FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, BEFORE THE USE OF THE ROBOT, THE COLOR OF THE TISSUE APPEARED DIFFERENT THAN EXPECTED WHEN USING THE SCHOELLY HANDHELD CAMERA. WHILE TEARING DOWN ADHESIONS, TISSUE WAS INJURED ("NICKED") RESULTING IN THE CUSTOMER "HAVING TO OPEN". THE CUSTOMER WANTED TO KNOW IF THE WHITE BALANCE SETTING COULD HAVE CAUSED THE ISSUE. THE TECHNICAL SUPPORT ENGINEER (TSE) ADVISED ENSURING THE WHITE BALANCE IS DONE CORRECTLY. IT IS UNCLEAR HOW THE PROCEDURE WAS COMPLETED. THE ROBOTICS COORDINATOR ATTRIBUTED THE EVENT TO USER ERROR AND REPORTED NO IDENTIFIED PROBLEMS. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195753 SCHOELLY CAMERA SCHOELLY CAMERA NAY INTUITIVE SURGICAL, INC 557072 UNKNOWN

    Patients

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