BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP S-9.0 TITANIUM

    MDR report key: 3232243 · Received July 8, 2013

    Report

    Report Number
    2647580-2013-00372
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 6, 2013
    Report Date
    June 12, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    FZP
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: VASCULAR. ACCORDING TO THE REPORTER: ACCORDING TO THE OPERATING ROOM NURSES STATEMENT WHEN THE DEVICE IS CLAMPING AND WHEN RETRIEVED, IT CUTS THE VESSELS. THE SURGEON WHEN MOBILIZING THE MAMMARY ARTERIES, USING THE AUTOMATIC CLIPS, CUT INTO ONE OF THE COLLATERALS AND IT WAS NECESSARY TO SUTURE WITH PROLENE STITCH. THE SITUATION WAS RECURRENT WHEN MOBILIZING THE OTHER MAMMARY ARTERY. IN THIS CASE THE SURGEON USED CLIPS IN THE AUTOMATIC APPLIER OF A BRAND THAT IS SELDOM USED IN THE OPERATING ROOM. THE JAWS DID NOT CROSS. THE CLIP DID NOT APPEAR TO BE SCISSORED. THERE WAS UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310290 PREMIUM SURGICLIP S-9.0 TITANIUM DISPOSABLE CLIP APPLIER FZP COVIDIEN, FORMERLY USSC P3B0418X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other