BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19490966 · Received June 7, 2024

    Report

    Report Number
    2955842-2024-15631
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    February 15, 2024
    Report Date
    May 13, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 (VSE) INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A DISLODGED GRIP RING AT THE PROXIMAL END INSIDE THE HOUSING. A DISLODGED GRIP RING CAN POTENTIALLY CAUSE THE INSTRUMENTS GRIPS TO NOT OPEN AND CLOSE PROPERLY. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED BLADE BASED ON IN-HOUSE TESTING. VISUAL INSPECTION SHOWED THAT THE BLADE WAS EXTENDED 0.129" OUTSIDE OF THE BLADE GARAGE. THERE WERE NO BIO DEBRIS FOUND AT THE INSTRUMENT TIP IN THE KNIFE TRACK. A REVIEW OF SYSTEM LOGS SHOWED NO BLADE EXPOSED/JAMMED FAILURE. COMPONENTS ADJACENT TO THIS DISLODGED BLADE DID NOT SHOW DAMAGE. THE INSTRUMENT FAILED SELF-CHECK WHEN INSTALLED ON THE SYSTEM. THE INSTRUMENT WAS RETURNED WITH AN EXPOSED BLADE. VISUAL INSPECTION SHOWED THAT THE BLADE WAS EXPOSED OUTSIDE OF THE BLADE GARAGE 0.116". THERE WERE MODERATE BIO DEBRIS FOUND AT THE INSTRUMENT TIPS. THE DISLODGED BLADE WAS LIKELY CAUSING FAILURE DURING INITIALIZATION. THERE WERE NO HOMING FAILURES FOUND IN THE LOGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT'S JAWS DID NOT OPEN. NO FRAGMENT FELL INTO THE PATIENT. THE USER COMPLETED THE PROCEDURE USING THE SAME SYSTEM. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USED AND NOTHING WAS OBSERVED OUT OF THE ORDINARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967448 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K17231026 0080 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES