BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 19294308 · Received May 10, 2024

    Report

    Report Number
    2955842-2024-14190
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    April 15, 2024
    Report Date
    April 15, 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
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE VESSEL SEALER EXTEND INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). FA WAS NOT ABLE TO CONFIRM OR REPRODUCE THE REPORTED COMPLAINT. THE PART WAS RETURNED WITH A REPORTED COMPLAINT THAT DOES NOT AFFECT FUNCTIONALITY. THE WHITE SUBSTANCE LOCATED AT THE DISTAL END OF THE INSTRUMENT HAS PREVIOUSLY BEEN IDENTIFIED BY MANUFACTURING AS KRYTOX LUBRICANT. NO DAMAGE FOUND. NO PRODUCT ISSUE WAS IDENTIFIED. A REVIEW OF THE SITE'S COMPLAINT HISTORY REVEALED THAT PATIENT IDENTIFIER 934376 IS A RELATED RECORDS (THE 2ND VESSEL SEALER EXTEND INSTRUMENT WITH AN EXCESS KRYTOX ISSUE FROM THE SAME PROCEDURE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, VESSEL SEALER EXTEND (VSE) INSTRUMENT HAD A WHITE SUBSTANCE IN AN EXCESS AMOUNT COMING OUT OF THE DEVICE. THE CUSTOMER HAD TWO DIFFERENT VSE INSTRUMENTS DISCHARGE A WHITE SUBSTANCE. THE CUSTOMER REPLACED THE FIRST INSTRUMENT AND NOTICED THE SECOND HAD THE SAME ISSUE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) EXPLAINED THE WHITE SUBSTANCE WAS LIKELY KRYTOX GREASE AND ADVISED TO SEND THE INSTRUMENT IN VIA RETURN MATERIAL AUTHORIZATION (RMA) FOR ANALYSIS. THE CUSTOMER NOTED THEY WERE NOT RETURNING THE SECOND VSE. THE SURGEON WAS CONTINUING AS PLANNED WITH NO FURTHER ISSUES. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: WITH BOTH VSE INSTRUMENT, THE KRYTOX FELL FROM THE INSTRUMENT INTO THE PATIENT. THE SURGEON USED A SUCTION IRRIGATOR, BUT REMOVAL OF THE KRYTOX WAS NOT CONFIRMED. THERE WERE NO POST-OPERATIVE COMPLICATIONS. THERE WAS NO PATIENT HARM. THE EVENT DATE WAS CONFIRMED TO BE (B)(6) 2024. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WAS REQUESTED, HOWEVER THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491080 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K12240127 0065 10886874115661

    Patients

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