BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 24629829 · Received March 18, 2026

    Report

    Report Number
    2955842-2026-16616
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 18, 2026
    Manufacturer
    SCHOELLY FIBEROPTIC GMBH
    Product Code
    GCJ
    UDI-DI
    04250480109076
    PMA / PMN Number
    K221591
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SCHOELLY HANDHELD CAMERA TO PERFORM FAILURE ANALYSIS. HOWEVER, AS OF THE DATE OF THIS REPORT, THE EVALUATION OF THE SCHOELLY HANDHELD CAMERA HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SCHOELLY HANDHELD CAMERA WAS NOT CONNECTING, AND COLOR BARS WERE DISPLAYED ON THE MONITOR OF THE VISION SIDE CART (VSC). THE CUSTOMER STATED THEY HAVE HAD MULTIPLE CONNECTION ISSUES WITH THE SCHOELLY HANDHELD CAMERA ASSOCIATED WITH THIS EVENT. IT WAS STATED THEY WOULD CLEAN THE CAMERA CONNECTOR WITH AN ALCOHOL WIPE AND "SOMETIMES THAT WOULD FIX THE CONNECTION ISSUE." HOWEVER, ONCE SENT THROUGH THE STERILIZATION PROCESS IT WOULD NO LONGER CONNECT. A BACKUP SCHOELLY HANDHELD CAMERA WAS REQUESTED AND INSTALLED WHICH CAUSED A 5-MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED PATIENT INJURY, AND THE PATIENT WAS DISCHARGED HOME THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686756 DA VINCI NIR HANDHELD CAMERA GCJ SCHOELLY FIBEROPTIC GMBH 470655-01 N/A 04250480109076

    Patients

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