BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 13895899 · Received March 24, 2022

    Report

    Report Number
    2955842-2022-10764
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    June 23, 2021
    Report Date
    February 24, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K150284
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT ORIGINATED FROM A MAUDE REPORT FROM AN UNKNOWN CUSTOMER SITE. INTUITIVE SURGICAL, INC. (ISI) WAS UNABLE TO PERFORM FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION DUE TO THE NATURE OF HOW THIS INFORMATION WAS COLLECTED. THE GENERIC XI PART NUMBER FOR THE MEGA NEEDLE DRIVER (PART # 470194) WAS USED TO CAPTURE THE INSTRUMENT, BUT ISI CANNOT CONFIRM IF IT WAS FOR THE XI SYSTEM. AS A RESULT, ADDITIONAL COMPLAINT INVESTIGATION COULD NOT BE PERFORMED SINCE THE SITE AND PRODUCT INFORMATION COULD NOT BE COLLECTED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT IS UNKNOWN IF A FRAGMENT FELL INSIDE THE PATIENT AND IT IS UNKNOWN IF POST-OPERATIVE TESTS WERE PERFORMED TO ATTEMPT TO LOCATE THE FRAGMENT. WHILE THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A MEGA NEEDLE DRIVER 10 HAD ONE LIFE LEFT. A SPRING ON THE MEGA NEEDLE DRIVER INSTRUMENT BROKE IN THE MIDDLE OF THE CASE. NO OTHER INFORMATION WAS PROVIDED. ON 24-FEB-2022, INTUITIVE SURGICAL, INC. BECAME AWARE OF MAUDE REPORT NUMBER: (B)(4). IT STATED "MEGA NEEDLE DRIVER 10 HAD ONE LIFE LEFT. MEGA NEEDLE DRIVER SPRING BROKE IN MIDDLE OF CASE. ISI UNABLE TO DETERMINE SITE/ACCOUNT DUE TO NO CONTACT/HOSPITAL INFORMATION PROVIDED FROM MAUDE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053236 ENDOWRIST MEGA NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 470194 UNKNOWN

    Patients

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