BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP S-9.0 TITANIUM

    MDR report key: 2821354 · Received October 25, 2012

    Report

    Report Number
    2647580-2012-00679
    Event Type
    Injury
    Date Received
    October 25, 2012
    Report Date
    October 8, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    FZP
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: BREAST REDUCTION. ACCORDING TO THE REPORTER: THE CLIP APPLIER WOULD DEPLOY TWO CLIPS WHEN THE HANDLE WAS SQUEEZED ONCE. ALSO, THE CLIPS WERE SCISSORING AND CUTTING THE STRUCTURES. THE CURRENT PATIENT STATUS IS FINE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. ANOTHER DEVICE WAS APPLIED TO CONTINUE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM SURGICLIP S-9.0 TITANIUM DISPOSABLE CLIP APPLIER FZP COVIDIEN, FORMERLY USSC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other