BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAUT DAVINCI BALLOON PORT

    MDR report key: 2110951 · Received May 4, 2011

    Report

    Report Number
    3003898360-2011-00222
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    March 3, 2011
    Report Date
    April 7, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT BEEN RECEIVED IN TIME FOR THIS REPORT, THEREFORE, INVESTIGATION IS COMPLETE. A F/U INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT RECEIVED VIA MED-WATCH. AT THE END OF THE DAVINCI ROBOTIC PROCEDURE, THE BALLOON PORT FOR THE PROCEDURE WAS REMOVED AND AFTER INSPECTION BY THE SCRUB RN TO CONFIRM INTEGRITY OF THE BALLOON PORT, THE SHEATH WAS NOTED TO HAVE A CIRCUMFERENTIAL CRACK. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAUT DAVINCI BALLOON PORT BALLOON PORT GCJ TELEFLEX MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK