BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21852795 · Received April 16, 2025

    Report

    Report Number
    2955842-2025-15499
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 27, 2025
    Report Date
    March 27, 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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM MONOPOLAR CURVED SCISSORS INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE CONTAMINATION ON BOTH BLADE(S). ONE BLADE/BOTH BLADES EXHIBITED MODERATE CONTAMINATION CORROSION ON THE OUTER &INNER CUTTING-EDGE SURFACES. WHEN SCRATCHED WITH A PICK, THE DEBRIS WAS ABLE TO BE REMOVED AND WAS NOT PITTED INTO THE BLADES. OTHER METAL COMPONENTS ADJACENT TO THIS CORRODED/CONTAMINATED BLADE(S) DO NOT SHOW DAMAGE. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE AT THE TIP OF THE BLADE. ONE OF THE BLADE EDGES WAS INDENTED WHICH PREVENT THE BLADES FROM CLOSING. THE CUTTING EDGE DID NOT EXHIBIT ANY SIGNS OF CORROSION THAT WOULD HAVE CONTRIBUTED TO THE BLADE DAMAGE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ACCORDING TO THE OPERATING ROOM (OR), THERE WERE NO INCIDENTS, NEITHER THAT A PATIENT WAS HARMED NOR THAT A REST FROM THE CABLE PULL REMAINED IN THE PATIENT. ALL OTHER QUESTIONS CANNOT BE ANSWERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM MONOPOLAR CURVED SCISSORS INSTRUMENT WAS CHARRED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133778 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-21 K13241017 0520 00886874112298

    Patients

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