BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16704616 · Received April 7, 2023

    Report

    Report Number
    2955842-2023-11847
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    March 15, 2023
    Report Date
    March 15, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112328
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SPARKING OF THE SPATULA, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED LOGS AND FOUND NO RELATED ERRORS. TSE INFORMED THE CUSTOMER THE REASONS FOR ARCING. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THE PERMANENT CAUTERY SPATULA INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE INSTRUMENT SPARKED/ARCED. THE ALLEGATION COULD BE RELATED TO THE POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. WHILE THERE WAS NO 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 RADICAL TONSILLECTOMY SURGICAL PROCEDURE, A SPARK WAS NOTED WHILE USING THE PERMANENT CAUTERY SPATULA INSTRUMENT. THE CUSTOMER CONFIRMED THAT THE SURGEON WAS AIR FIRING THE INSTRUMENT. WHEN THE INSTRUMENT COMES CLOSE TO TISSUE, WHILE STILL BEING FIRED, THE INSTRUMENT SPARKS TO THE TISSUE AND THIS INTERMITTENTLY CONTINUED TO OCCUR AS THE SURGEON IS CAUTERIZING TISSUE. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED LOGS AND FOUND NO RELATED ERRORS. TSE INFORMED THE CALLER THAT THE ENERGIZED ENERGY TIP IS FINDING GROUND, SUBSEQUENTLY LEADING TO ARCING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO NOTED DAMAGE ON THE INSTRUMENT. THE INSTRUMENT THAT EXPERIENCED THE ARCING EVENT WAS THE FIRST INITIALLY USED INSTRUMENT. THERE IS A METAL RETRACTOR HOLDING THE PATIENT'S MOUTH OPENED AND IT WAS SUSPECTED TO HAVE CAUSED THE ARCING. THE SURGEON AIR-FIRED THE INSTRUMENT INSTEAD OF WAITING FOR TISSUE CONTACT. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO COMPLICATIONS. THERE WAS NO VIDEO OR IMAGING. THE PATIENT DEMOGRAPHIC INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794301 ENDOWRIST PERMANENT CAUTERY SPATULA NAY INTUITIVE SURGICAL, INC 470184-13 N10201117 0018 00886874112328

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.