BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22580940 · Received July 23, 2025

    Report

    Report Number
    2955842-2025-31326
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    July 2, 2025
    Report Date
    July 2, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE BLADE DAMAGE AT THE TIP OF THE BLADE. BOTH OF THE BLADE EDGES WAS INDENTED. THE BLADE INDENTATION DID CAUSE THE CUT TEST FAILURE AND CAUSED THE BLADES NOT TO OPEN OR CLOSE PROPERLY. THE CUTTING EDGE HAD CORROSION THAT WOULD HAVE CONTRIBUTED TO THE BLADE DAMAGE OR CUTTING FAILURE. THE COMPLAINT REGARDING GOUGE IN SCISSOR BLADE WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF NICKS AND GOUGES ON THE INSTRUMENT BLADES IS ATTRIBUTED TO USE-RELATED DAMAGE WHEN ATTEMPTING TO CUT INCOMPATIBLE MATERIAL (I.E., HARD OBJECTS SUCH AS BONE OR CARTILAGE) OR MISHANDLING THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI), HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT HAD A GOUGE IN THE BLADE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. 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
    986083 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23 K10250115 0166 00886874112298

    Patients

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