BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 23918674 · Received December 29, 2025

    Report

    Report Number
    2955842-2025-49663
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 29, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE SYSTEM LOGS DID NOT REVEAL ANY SYSTEM-RELATED ERROR WHICH MAY HAVE BEEN IN ASSOCIATION WITH THE CUSTOMER-REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED APPENDECTOMY PROCEDURE, THE LAPAROSCOPIC SCHOELLY CAMERA WAS PLACED ON THE SIDE OF THE BED AND SUBSEQUENTLY BURNED THROUGH THE STERILE DRAPE, CAUSING TWO BURN HOLES IN THE GROIN AREA OF THE REGISTERED NURSE FIRST ASSISTANT (RNFA). THE INCIDENT OCCURRED AFTER THE CAMERA HAD BEEN USED FOR ABDOMINAL ENTRY. A RED LIGHT, DESCRIBED AS RESEMBLING A LASER ICON, APPEARED ON THE CAMERA ALONG WITH A MESSAGE INDICATING THAT A LASER-TYPE MODE WAS ACTIVE. AFTER THIS MESSAGE APPEARED, THE CAMERA WAS SET ON THE BEDSIDE WHERE INSTRUMENTS ARE PLACED, AT WHICH POINT THE RNFA SUSTAINED THE BURN INJURY. IT IS UNKNOWN WHETHER THE NURSE¿S SKIN WAS BURNED OR WHETHER MEDICAL TREATMENT WAS REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER COMPLICATIONS, AND THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT THE CUSTOMER HAS INDICATED THAT NO FURTHER INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768642 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-46 N/A 00886874119662

    Patients

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