BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 19631616 · Received June 28, 2024

    Report

    Report Number
    2955842-2024-16237
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    June 6, 2024
    Report Date
    June 6, 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
    FR
    Reporter Occupation
    003

    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 FOUND TO HAVE SMALL AMOUNTS OF A WHITE SUBSTANCE ON THE DISTAL END NEAR THE GRIPS. THIS SUBSTANCE WAS USED DURING THE MANUFACTURING PROCESS AND CAN BE FOUND ON THE INSTRUMENT IN SOME CASES. THIS PRODUCT WAS CONFORMING AND CAN BE USED SAFELY. NO PROBLEM WITH THE DEVICE WAS DETECTED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    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 TRIPLE-WAY ESOPHAGECTOMY SURGICAL PROCEDURE, WHEN USING THE VESSEL SEALER (VS), THEY NOTICED THAT A WHITE PART OF THE CLAMP WAS INCREASINGLY VISIBLE. ACCORDING TO THE SURGEON, SMALL WHITE DEBRIS FELL INTO THE PATIENT AND WAS NOT FOUND. AFTER TAKING OUT THE TWEEZERS AND LOOKING CLOSER AT THE WHITE PART, THE FRAGMENT THAT FELL LOOKED LIKE SILICONE. THE PROCEDURE WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819884 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L88240109 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES