BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP M-11.5 TITANIUM

    MDR report key: 1081259 · Received July 23, 2008

    Report

    Report Number
    2647580-2008-00424
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    August 28, 2007
    Report Date
    July 1, 2008
    Manufacturer
    PONCE- USS
    Product Code
    GDO
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: WHILE USING THE MEDIUM CLIP APPLIER ON DIEP FLAP, ON A NUMBER OF OCCASIONS THE CLIP CAUSED THE VESSEL TO BLEED AND DID NOT OCCLUDE THE VESSEL. ALSO THE TIPS OF THE CLIPS CROSSED OVER ON THEMSELVES INSTEAD OF MEETING. THE SURGERY WAS COMPLETED WITH NO FURTHER REPORT OF PT COMPLICATIONS. PT DIAGNOSIS PRE AND POST OPERATIVE: SURGICAL DEFECT OF RIGHT BREAST STATUS POST RIGHT MASTECTOMY FOR IMMEDIATE RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM SURGICLIP M-11.5 TITANIUM SURGICAL CLIP APPLIER GDO PONCE- USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention