BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 25002513 · Received April 27, 2026

    Report

    Report Number
    2955842-2026-22961
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 27, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT TO PERFORM FAILURE ANALYSIS. CONCOMITANT PRODUCTS: MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT (PART NUMBER: 470179-23). .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, TISSUE GRASPED BY THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT WAS UNINTENTIONALLY BURNED WHILE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS IN USE. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONSULTED AND RECOMMENDED REAPPLYING THE GROUNDING PAD TO IMPROVE CONDUCTIVITY. THE GROUNDING PAD WAS SUBSEQUENTLY ADJUSTED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE CAUSE OF THE INCIDENT REMAINS UNDETERMINED, AS NO ARCING WAS OBSERVED WITH THE MCS INSTRUMENT. THE FOLLOWING DETAILS ALSO REMAIN UNKNOWN: THE CAUSE OF THE BURN INJURY, THE EXTENT OF THE TISSUE BURN, AND WHETHER ANY MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45211 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-30 N/A 00886874110898

    Patients

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