BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 MM INSTRUMENT CANNULA

    MDR report key: 3881527 · Received June 18, 2014

    Report

    Report Number
    2955842-2014-03741
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCESSORY WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE CANNULA FAILED GAGE PIN CHECK. THE GAGE PIN DID NOT PASS ALL THE WAY THROUGH THE CANNULA. GAGE PIN GOT STUCK AT THE TIP OF THE CANNULA. EVIDENCE NOT CONCLUSIVE BUT FAILED GAGE PIN CHECK MAY BE DUE TO LIKELY MISHANDLING/MISUSE. NO OTHER DAMAGE FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS -HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER FAILED GAGE PIN CHECK TEST WERE TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER COMPLETION OF A DA VINCI PROCEDURE, THE 8MM CANNULA FAILED GAGE PIN CHECK. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357502 8 MM INSTRUMENT CANNULA ENDOSCOPIC INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 420002-02 SA082302

    Patients

    Seq Age Sex Outcome Treatment
    1