BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 15325314 · Received August 30, 2022

    Report

    Report Number
    2955842-2022-13756
    Event Type
    Malfunction
    Date Received
    August 30, 2022
    Date of Event
    July 7, 2022
    Report Date
    August 1, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT ORIGINATED FROM MW5110976. INTUITIVE SURGICAL, INC. (ISI) HAS MADE SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER WITH NO SUCCESS TO OBTAIN INFORMATION RELATED TO THE PRODUCT INVOLVED IN THIS COMPLAINT. MW5110976 PROVIDED THE PART NUMBER FOR A VESSEL SEALER EXTEND INSTRUMENT AND STATED THE STAPLER MALFUNCTION: INCOMPLETE STAPLE. THE REPORT LISTED THE MANUFACTURER NAME AS INTUITIVE SURGICAL, BUT ALSO LISTED THE COMPANY STANDARD BARIATRICS FOR THE STANDARD BARIATRIC TITAN INSTRUMENT. AT THIS TIME, THE ACTUAL INSTRUMENT TYPE IS NOT KNOWN. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE FAILURE ANALYSIS OF THE PRODUCT CANNOT BE PERFORMED. DUE TO LIMITED PRODUCT INFORMATION BEING PROVIDED, NEITHER AN INSTRUMENT NOR SYSTEM LOG REVIEW COULD BE PERFORMED. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: IT WAS ALLEGED DURING A PROCEDURE, THE VESSEL SEALER EXTEND INSTRUMENT MALFUNCTIONED AND DID AN INCOMPLETE STAPLE. WHILE THERE WAS NO REPORTED 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

    ON 01-AUG-2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5110976 STATING: STAPLER MALFUNCTION: INCOMPLETE STAPLE. FDA SAFETY REPORT ID # (B)(4). ISI FOLLOWED UP WITH THE INITIAL REPORTER AND COULD NOT GET ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067566 DA VINCI DA VINCI INSTRUMENT NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

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