BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24154818 · Received January 22, 2026

    Report

    Report Number
    2955842-2026-01874
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    January 6, 2026
    Report Date
    January 22, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE CONFIRMED THAT THE EXTERNAL PEDALS WERE CAUSING AN M-12 ERROR AND REPLACED BOTH MONOPOLAR AND BIPOLAR PEDALS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE OF ERROR M-12 IS DUE TO THE ACTIVATION WAS ALREADY REQUESTED WHEN THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE WAS POWERED ON OR WHEN MODULE WAS CONNECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA BILATERAL SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE TECHNICAL SUPPORT ENGINEER REGARDING ENERGY CONTINUING AFTER THE EXTERNAL MONOPOLAR FOOT PEDAL HAD BEEN RELEASED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING A SURGICAL PROCEDURE INVOLVING THE PREPARATION OF THE PERITONEAL FLAP IN AN ETEP HERNIA REPAIR, A LAPAROSCOPIC MONOPOLAR HOOK WAS USED WITH THE MONOPOLAR CAUTERY SET TO LEVEL 4. AN UNINTENDED ENERGY DISCHARGE OCCURRED, AFFECTING AN AREA NOT INTENDED TO BE CAUTERIZED. HOWEVER, THE OPERATION OF THE INSTRUMENT WAS PROMPTLY CEASED, AND NO PATIENT INJURY OR HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215755 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES