BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE CURVED CANNULA

    MDR report key: 3872764 · Received June 13, 2014

    Report

    Report Number
    2955842-2014-03639
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCESSORY WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE TUBE OF THE CANNULA AND THE WELD BETWEEN THE BOWL AND TUBE HAD BOTH BROKE. AS A RESULT, THE TUBE WAS DETACHED FROM THE BOWL. EVIDENCE NOT CONCLUSIVE BUT BROKEN CANNULA 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 THE BROKEN CANNULA WERE TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI CHOLECYSTECTOMY PROCEDURE THAT THE 5X300MM CURVED CANNULA BALL BROKE OFF FROM THE STEM OF THE CANNULA. 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
    349726 SINGLE-SITE CURVED CANNULA ENDOSCOPIC ACCESSORY NAY INTUITIVE SURGICAL,INC. 428061-03 VE132210

    Patients

    Seq Age Sex Outcome Treatment
    1