BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 20100008 · Received August 29, 2024

    Report

    Report Number
    2955842-2024-18015
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 2, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS TESTING. THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS RETURNED AND ANALYZED. THE WHITE SUBSTANCE LOCATED AT THE DISTAL END OF THE INSTRUMENT WAS IDENTIFIED AS KRYTOX LUBRICANT AND NO DAMAGE WAS FOUND. NO PRODUCT ISSUE WAS IDENTIFIED. THE REPORTED DEVICE WAS FOUND TO BE WITHIN EXPECTED CONDITION.

    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 H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY NON-TRANSTHORACIC TRANS CERVICAL SURGICAL PROCEDURE, THE LUBRICANT REPEATEDLY LEAKED FROM THE VESSEL SEALER EXTEND (VSE) INSTRUMENT JAW. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: WHITE LUBRICANT FELL INTO THE PATIENT AND NO PATIENT HARM WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803231 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-03 K19240222 0000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES