BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22539284 · Received July 18, 2025

    Report

    Report Number
    2955842-2025-30477
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 25, 2025
    Report Date
    June 25, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISIFA2022-01-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN RMA WAS NOT ISSUED FOR RETURN AS THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS DISPOSED. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. FAILURE ANALYSIS ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: "IT LOOKS LIKE THERE COULD BE EXCESSIVE KRYTOX LUBRICANT AT THE DISTAL END OF THE INSTRUMENT. THE PICTURES ARE VERY ZOOMED IN SO IT LOOKS EXCESSIVE FOR SURE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, CUSTOMER REPORTED THEY WERE USING THE VESSEL SEALER DURING A SIGMOID COLECTOMY. AT THE END OF THE PROCEDURE THEY NOTICED SOMETHING WHITE COMING OUT OF THE VESSEL SEALER. IT LOOKED LIKE IT COULD BE SOME KIND OF LUBRICANT. THEY FINISHED THE PROCEDURE AND THE INSTRUMENT WAS THROWN AWAY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878503 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-03 K18250110 0302 10886874115661

    Patients

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