BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 21997515 · Received May 9, 2025

    Report

    Report Number
    2955842-2025-18856
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    April 9, 2025
    Report Date
    April 9, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114742
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SITE VISIT WAS MADE BY THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) AND THE SYSTEM WAS TESTED, BUT NO ISSUE WAS FOUND. THE SYSTEM WAS TESTED AND VERIFIED FOR USE. THE MONOPOLAR CURVED SCISSORS (MCS) USED WAS RETURNED FOR FAILURE ANALYSIS (FA). THE INSTRUMENT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TEST, MOVED INTUITIVELY WITH FULL RANGE OF MOTION, AND THE INSTRUMENT TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS CONNECTED TO AN IN-HOUSE ERBE ENERGY GENERATOR AND THE INSTRUMENT WAS RECOGNIZED WITH NO ISSUES AND PASSED THE ENERGY DELIVERY TEST. A SYSTEM LOG REVIEW FOR THE ASSOCIATED PROCEDURE WAS PERFORMED AND CONFIRMED THE OCCURRENCE OF THE CUSTOMER REPORTED ERROR, HOWEVER, NO HARDWARE ISSUE COULD BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NIPPLE-SPARING MASTECTOMY, THE CUSTOMER RECEIVED A "REPLACE INSTRUMENT SHEATH" MESSAGE WHEN USING MONOPOLAR ENERGY. THE SHEATH, TIP, CAUTERY CABLE AND GROUND PAD WERE REPLACED, AND THE ISSUE WAS RESOLVED TEMPORARILY, HOWEVER, THE ERROR OCCURRED SEVERAL TIMES. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT ISSUE REPORTED. HOWEVER, ON THE SURGERY DATE, NECROSIS OF THE BREAST TISSUE WAS NOTED. THE SURGEON DOES NOT THINK AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT CAUSED OR CONTRIBUTED TO THE NECROSIS, BUT DOES THINK THAT THE CAUSE OF THE SHEATH MESSAGING WAS A SYSTEM/INSTRUMENT ISSUE. INSTEAD, THE SURGEON THINKS THE CAUSE OF THE NECROSIS WAS A "SURGICAL ISSUE." ONLY THE MONOPOLAR ENERGY INSTRUMENT EXPERIENCED ISSUES. THERE WAS NO REPORT OF ARCING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909630 DA VINCI SP VISION SYSTEM CART NAY INTUITIVE SURGICAL, INC 380941-40 N/A 00886874114742

    Patients

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