BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS BTT/ROUND BALLOON DISSECTOR

    MDR report key: 3883160 · Received February 19, 2014

    Report

    Report Number
    2647580-2014-00102
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 28, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT SENT ON 02/19/2014.

    Description of Event or Problem · 1

    PROCEDURE TYPE: TEP. ACCORDING TO THE REPORTER: WHEN A SURGEON TRIED TO INFLATE A BALLOON, IT BURST. SO HE COULDN'T USE IT. THERE WAS NO PT INVOLVEMENT. THERE WAS NOT ANY REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE. THE SURGICAL TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. THE SUBJECT DEVICE WILL BE RETURNED FOR INVESTIGATION. THERE WAS NO UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM. THERE WAS NOT BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105900 SM PLUS BTT/ROUND BALLOON DISSECTOR SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P2F0820X

    Patients

    Seq Age Sex Outcome Treatment
    1