BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 25224187 · Received May 19, 2026

    Report

    Report Number
    2955842-2026-25036
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    March 4, 2026
    Report Date
    May 19, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE. BOTH OF THE BLADE EDGES WERE INDENTED. THE CUT TEST COULD NOT BE PERFORMED BECAUSE THE BLADE INDENTATION PREVENTED THE BLADES FROM CLOSING PROPERLY. THE CUTTING EDGE(S) DID NOT HAVE CORROSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT BLADES WERE DULL AND SEEMED TO TEAR TISSUE. THE FOLLOWING INFORMATION IS UNKNOWN: WHAT TISSUE WAS AFFECTED, THE SEVERITY OF THE TISSUE DAMAGE, AND WHAT SURGICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE COMPLICATION. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457338 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23 K13260123 0287 00886874112298

    Patients

    Seq Age Sex Outcome Treatment
    1