BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE 5 X 250 MM CURVEDCANNULA, ARM 1

    MDR report key: 5804562 · Received July 19, 2016

    Report

    Report Number
    2955842-2016-00505
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    June 27, 2016
    Report Date
    June 27, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112208
    Removal / Correction Number
    2955842-02-28-2014-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CANNULA INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED FAILURE MODE. THE CANNULA EXHIBITED A WELD DEFECT. THE CANNULA BASE WAS DETACHED FROM THE SHAFT COMPLETELY. IN MAY 2014, FIELD SAFETY NOTICE 2955842-02-28-2014-001-R WAS DELIVERED TO THE SITE AND ACKNOWLEDGED. THE FIELD SAFETY NOTICE REQUESTED FOR ALL SINGLE-SITE 5MM CURVED CANNULA INCLUDING PART 428071-03 TO BE REPLACED AND RETURNED. THIS COMPLAINT IS BEING REPORTED DUE TO THE CANNULA BASE BEING DETACHED FROM THE CANNULA SHAFT; IF THE REPORTED MALFUNCTION WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING CENTRAL PROCESSING, THE LONG TUBE WAS DETACHED ON THE 5MM CURVED CANNULA. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR ANY INDICATION THAT AN ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458324 SINGLE-SITE 5 X 250 MM CURVEDCANNULA, ARM 1 ENDOSCOPIC ACCESSORY NAY INTUITIVE SURGICAL,INC. 428071-03 VE120301

    Patients

    Seq Age Sex Outcome Treatment
    1