BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22377793 · Received July 1, 2025

    Report

    Report Number
    2955842-2025-28166
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    April 5, 2025
    Report Date
    June 10, 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
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE SEVERAL BLADE DAMAGES ON THE ENTIRE BLADE. ONE OF THE BLADE EDGES WAS INDENTED. THE SCISSOR BLADES WERE TINGED AND SHOWED SIGNS OF USAGE. THE CUTTING EDGE DID NOT HAVE CORROSION THAT WOULD HAVE CONTRIBUTED TO THE BLADE DAMAGE OR CUTTING FAILURE. BLADES OF AN INSTRUMENT THAT HAD BURRS OR INDENTATIONS WOULD NOT BE ABLE TO CUT MATERIAL AS EXPECTED, LEADING TO THE NEED TO ATTEMPT MULTIPLE CUTS TO COMPLETE A TRANSECTION. THE COMPLAINT 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) FAILURE ANALYSIS ADDITIONAL OBSERVATION FOUND THE MONOPOLAR CURVED SCISSORS INSTRUMENT TO HAVE PARTS OF THE BLADE EDGE MISSING. THE SIZE OF THE MISSING PARTS IS UP TO 0.7MM. COMMON CAUSES OF FAILURE MODE DETACHED FRAGMENTS ARE ATTRIBUTED TO USE-RELATED DAMAGE WHEN ATTEMPTING TO CUT INCOMPATIBLE MATERIAL, SUCH AS HARD OBJECTS LIKE BONE OR CARTILAGE, OR FROM MISHANDLING OR MISUSING THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE MONOPOLAR CURVED SCISSORS INSTRUMENT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE OF METAL HAD BROKEN OFF ON THE CUTTING SURFACE OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DAMAGE TO THE SCISSORS WAS NOTICED DURING REPROCESSING. THERE WAS NO IMPACT TO THE PATIENT. THE SCISSORS WERE RETAINED TO CLARIFY WHETHER WE NEEDED TO REPORT THE DAMAGE ELSEWHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206708 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-21 K10241114 0718 00886874112298

    Patients

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