BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 18627214 · Received February 1, 2024

    Report

    Report Number
    2955842-2024-10912
    Event Type
    Injury
    Date Received
    February 1, 2024
    Date of Event
    January 8, 2024
    Report Date
    January 8, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VESSEL SEALER EXTEND TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF "A WHITE MASS (A TYPE OF FAT) EMERGED FROM THE FRONT JOINT OF THE VESSEL SEALER EXTEND, WHICH ONLY BECAME VISIBLE DURING THE OPERATION AND THUS REACHED THE OPERATING AREA". THE WHITE RESIDUE THAT HAS CONSOLIDATED WITHIN THE WRIST ASSEMBLY IS KRYTOX GREASE (PN#975017). PER THE MANUFACTURING PROCEDURE, KRYTOX IS APPLIED AT THE WRIST SEAL WHERE WRIST CABLES AND CAUTERY WIRE GO THROUGH. THIS INSTRUMENT APPEARED TO HAVE KRYTOX APPLIED AND AGGREGATED AT A COMMON LOCATION DURING THE WRIST ASSEMBLY PROCESS. PER INTUITIVE GUIDELINES, THE AMOUNT OF KRYTOX SEEN ON THIS INSTRUMENT AT THE TIME OF FAILURE ANALYSIS IS A PASSING CRITERION AND AN EXPECTED CONDITION. THE INSTRUMENT WAS PLACED ON THE SYSTEM AND DRIVEN AT VARIOUS ANGLES. ENERGY DELIVERY WAS PERFORMED AND PASSED AND NO OOZING OF KRYTOX OCCURRED DURING IN-HOUSE TESTING. THE INSTRUMENT WAS ALSO FOUND TO HAVE A SEGMENT OF THE CONDUCTOR WIRE STICKING OUT FROM THE WRIST ASSEMBLY. A LOOP OF WIRE IS STICKING OUT SUCH THAT THE WIRE PROTRUDES ABOVE THE OUTER SURFACE OF THE MAIN TUBE. THE WIRE INSULATION WAS NOT DAMAGED, AND THE INSTRUMENT PASSED AN ELECTRICAL CONTINUITY TEST. COMPONENTS ADJACENT TO THE DISLODGED WIRE DOES NOT SHOW DAMAGE.

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ISI HAS NOT RECEIVED THE INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. .

    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 SURGICAL PROCEDURE, A WHITE MASS (RESEMBLING A TYPE OF FAT) EMERGED FROM THE FRONT JOINT OF THE VESSEL SEALER EXTEND, WHICH ONLY BECAME VISIBLE DURING THE OPERATION AND THUS REACHED THE OPERATING AREA. THE MASS WAS NOT VISCOUS BUT RATHER SOLID AND LAY IN SMALL PIECES IN THE SURGICAL AREA BUT COULD BE CRUSHED OUTSIDE THE SITE. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE VESSEL SEALER EXTEND (VSE) WAS INSPECTED AND FOUND TO HAVE NO ABNORMALITIES. THE ISSUE WAS WITH A SOFT/TOUGH MASS, NOT A HARD FRAGMENT. THE PROBLEM WAS IDENTIFIED DURING A SURGICAL TASK AND THE VESSEL SEALER EXTEND WAS REPLACED WITH A NEW ONE FROM A DIFFERENT BATCH. THE VESSEL SEALER EXTEND WAS EASILY REMOVED WITHOUT ANY PROBLEMS THROUGH THE CANNULA. THE MASS INSIDE THE PATIENT WAS IMMEDIATELY REMOVED USING FORCEPS. THERE ARE NO KNOWN POSTOPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249244 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K17230901 0901 10886874115661

    Patients

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