BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20680433 · Received November 14, 2024

    Report

    Report Number
    2955842-2024-21926
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 23, 2024
    Report Date
    October 23, 2024
    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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. 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 (MCS) INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE DISCOLORATION ON BOTH OF THE BLADE TIPS. THIS DISCOLORATION IS NOT RESIDUAL SOIL AND DOES NOT NEED TO BE COMPLETELY REMOVED. THIS DARKENING IS CAUSED BY IRON OXIDE AND IS A CHEMICAL CHANGE IN THE BLADE MATERIAL AND NOT A RESULT OF MISHANDLING/MISUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8MM MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS OBSERVED TO BE MELTED AT THE TIP/INSULATION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED FOR DAMAGE PRIOR TO REPROCESSING, AND IT WAS CONFIRMED THAT THE OBSERVED THERMAL DAMAGE WAS IDENTIFIED PRIOR TO REPROCESSING, FOLLOWING COMPLETION OF THE PRIOR PROCEDURE. THERE WAS NO REPORT OR OBSERVATION OF ARCING DURING THE PRIOR PROCEDURE IN WHICH THE INSTRUMENT WAS USED. THE CUSTOMER ADDITIONALLY CONFIRMED THAT THERE WAS NO REPORTED PATIENT INJURY DURING LAST PROCEDURAL USE OF THE INSTRUMENT AND NO INCIDENT REPORTS WERE RECEIVED REGARDING THE INSTRUMENT. PATIENT DEMOGRAPHICS AND PATIENT-RELATED INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205368 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K11240314 0421 00886874112298

    Patients

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