BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 19787638 · Received July 20, 2024

    Report

    Report Number
    2955842-2024-17156
    Event Type
    Injury
    Date Received
    July 20, 2024
    Date of Event
    June 27, 2024
    Report Date
    June 27, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE VESSEL SEALER EXTEND (VSE) INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE INSTRUMENT WAS RETURNED WITH A REPORTED COMPLAINT THAT DOES NOT AFFECT FUNCTIONALITY OF THE INSTRUMENT. A WHITE SUBSTANCE WAS REPORTEDLY COMING OUT OF THE JAWS OF THE INSTRUMENT. THE WHITE SUBSTANCE OBSERVED ON THE DISTAL END OF THE INSTRUMENT IS KNOWN AS KRYTOX AND IS USED DURING THE MANUFACTURING PROCESS. THE AMOUNT OF KRYTOX OBSERVED DURING VISUAL INSPECTION WAS NOT CONSIDERED TO BE EXCESSIVE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE FAE INDICATED THAT THE IMAGE LOOKED LIKE A CASE OF EXCESSIVE KRYTOX LUBRICANT AT THE DISTAL END OF THE INSTRUMENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, A WHITE SUBSTANCE ALLEGEDLY STARTED COMING OUT OF THE JAWS OF THE VESSEL SEALER EXTEND (VSE) INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTICS COORDINATOR INFORMED THAT THE VSE INSTRUMENT WAS USED ON THE PATIENT AND THE SURGEON INDICATED THAT IT WAS LIKELY THAT SOME OF THE EXCESSIVE LUBRICANT FELL INTO THE PATIENT. ALTHOUGH THIS WAS ALLEGED, THERE WAS NO ATTEMPT TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032473 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 N/A 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other DA VINCI INSTRUMENTS AND ACCESSORIES