BEUDAMED
    FDA Adverse Event Injury Summary report: N

    133650 PREMIUM SURGICLIP III 9.0

    MDR report key: 6236391 · Received January 10, 2017

    Report

    Report Number
    2647580-2017-00026
    Event Type
    Injury
    Date Received
    January 10, 2017
    Date of Event
    December 8, 2016
    Report Date
    December 13, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    FZP
    UDI-DI
    10884521517394
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). USER FACILITY IS LISTED IN INITIAL REPORTER. (B)(4). POST MARKET VIGILANCE (PMV) AND ENGINEERING CONCURRENTLY LED AN EVALUATION OF ONE CLIP APPLIER OPENED. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, ENGINEERING REVIEW OF THE PRODUCT AND AN EVALUATION OF THE RETURNED DEVICE. THE INSTRUMENT WAS RECEIVED PARTIALLY APPLIED WITH SEVENTEEN REMAINING CLIPS. VISUAL INSPECTION OF THE INSTRUMENT REVEALED NO ABNORMALITIES. FUNCTIONALLY, THE INSTRUMENT WAS FIRED ONCE IN AIR AND PROPER CLIP FORMATION WAS CONFIRMED. THE REMAINING CLIPS WERE THEN FIRED ON TEST MEDIA WITH PROPER FORMATION. THE JAW AND HANDLE MOVED SMOOTHLY THROUGH THE FIRING CYCLE AND RETURNED TO THE OPEN POSITION AND EACH REMAINING CLIP LOADED PROPERLY IN THE JAW. WHEN THE CARTRIDGE WAS EMPTY, THE INTERLOCK ENGAGED AND PREVENTED THE JAW FROM APPROXIMATING. IN ADDITION; THE INSTRUMENT WAS DISASSEMBLED FOR VISUALIZATION OF INTERNAL COMPONENTS AND REVEALED NO ABNORMALITIES. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT INVOLVING THE LIMA THE USER FIRED A CLIP ON THE LEFT INTERNAL MAMMARY ARTERY AND IT SHEARED THE BRANCH. THE CLIPS FELL INTO THE PATIENT CAVITY WAS RETRIEVED BY GRASPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20452 133650 PREMIUM SURGICLIP III 9.0 CLIP, IMPLANTABLE FZP COVIDIEN, FORMERLY USSC PUERTO RICO INC 133650 P6K0037X 10884521517394

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability