BEUDAMED
    FDA Adverse Event Injury Summary report: N

    133650 PREMIUM SURGICLIP III 9.0

    MDR report key: 6394997 · Received March 10, 2017

    Report

    Report Number
    2647580-2017-05068
    Event Type
    Injury
    Date Received
    March 10, 2017
    Report Date
    February 13, 2017
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    FZP
    PMA / PMN Number
    K142869
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A CORONARY ARTERY BYPASS PROCEDURE, THE CLIPS WERE DOUBLE FIRING AND SCISSORING. TO CORRECT THIS ISSUE, THE CLIP LINE HAD TO BE OVER SEWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178824 133650 PREMIUM SURGICLIP III 9.0 CLIP, IMPLANTABLE FZP US SURGICAL PUERTO RICO 133650 P6K0037X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention