BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM CANNULA ACCESSORY

    MDR report key: 3061948 · Received April 16, 2013

    Report

    Report Number
    2955842-2013-01259
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THAT THE RETURNED CANNULA WAS OUT OF ROUND. THE 0.226 DIAMETER GAGE PIN WOULD FIT THROUGH THE DISTAL END OPENING; HOWEVER, THE CANNULA'S TUBE WAS FOUND BENT. ROTATION OF THE CANNULA WHILE LAYING ON ITS SIDE SHOWED A SLIGHT BEND NEAR THE MIDPOINT OF THE TUBE. VISUAL INSPECTION OF CANNULA SHOWED NO DAMAGE AT THE DISTAL END OPENING. ENGINEERING CONCLUDED THAT THE DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) 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 REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE USER FACILITY IDENTIFIED A CANNULA THAT WAS REPORTEDLY OUT OF ROUND AND WAS SCRATCHING INSULATION FROM THE INSTRUMENTS. NO MISSING OR FALLEN PIECES WERE REPORTED. THE INSTRUMENT REPORTEDLY WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162308 5MM CANNULA ACCESSORY ENDOSCOPIC ACCESSORY NAY INTUITIVE SURGICAL,INC. 420011-05 SA114704

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES