BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 22080692 · Received May 23, 2025

    Report

    Report Number
    2955842-2025-20965
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    April 23, 2025
    Report Date
    April 28, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114742
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE PERFORMED FUNCTIONAL TESTS ON THE SYSTEM AND NO TROUBLE WAS FOUND. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. DUE TO INSUFFICIENT PROCEDURAL INFORMATION, FURTHER SYSTEM/INSTRUMENT LOG INVESTIGATION CANNOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER COMPLETING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, A BURN WAS IDENTIFIED ON THE PATIENT'S BACK. THE FOLLOWING INFORMATION IS UNKNOWN: THE CAUSE AND SEVERITY OF THE BURN INJURY, AND WHAT MEDICAL INTERVENTION (IF ANY) WAS ADMINISTERED DUE TO THE COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2321000 DA VINCI SP VISION SYSTEM CART NAY INTUITIVE SURGICAL, INC 380941-50 N/A 00886874114742

    Patients

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