BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17221695 · Received June 28, 2023

    Report

    Report Number
    2955842-2023-16671
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 2, 2023
    Report Date
    June 2, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED THE PRODUCT EVALUATION. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE OR CONFIRM THE CUSTOMER REPORTED COMPLAINT. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS AND MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED THE SUTURE NEEDLE HANDLING TEST AND WAS ABLE TO SUCCESSFULLY TIE A KNOT. THE INSTRUMENT WAS FULLY FUNCTIONAL. THERE WAS NO PROBLEM DETECTED.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE MOTION WITH MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT , AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. HOWEVER, THE ANALYSIS IS NOT YET COMPLETED. FOLLOW UP MDR WILL BE SUBMITTED WITH ANALYSIS FINDINGS.

    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 HIATAL HERNIA PARAESOPHAGEAL SURGICAL PROCEDURE, THERE WERE DIFFICULTIES TO TIE SUTURE WITH 8MM MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT MULTIPLE TIMES AND THE INSTRUMENT FAILED TO COMPLETE TYING MOTION. SURGEON ATTEMPTED MULTIPLE TIMES AND EVEN DEMONSTRATED TO THE ROOM THAT IT WOULD NOT COMPLETE INTENDED MOTION. SURGEON MODIFIED HIS TECHNIQUE AT SURGEON SIDE CONSOLE (SSC) TO COMPLETE THE PROCEDURE. SURGEON WAS TRYING TO ROTATE HAND AND ANGLE THE INSTRUMENT TIP AND IT WOULD NOT COMPLETE THE INTENDED ACTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC.(ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150642 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-15 K11230122 0066 00886874119815

    Patients

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