BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE LOADING UNIT

    MDR report key: 3964215 · Received July 14, 2014

    Report

    Report Number
    2647580-2014-00527
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ILEAL CONDUIT CONSTRUCTION. ACCORDING TO THE REPORTER: TWO DAYS AFTER THE OPERATION, SHE WAS REOPERATED BECAUSE OF ANASTOMOTIC LEAKAGE. A LARGE DEFECT WAS DETECTED AT THE ANASTOMOTIC LINE, AND HERE SEVERAL STAPLES THAT WERE NOT CLOSED PROPERLY WERE DETECTED. THE PATIENT HAD PERITONITIS, AND A STOMA WAS CREATED. SHE WAS TREATED INITIALLY LEAVING THE ABDOMEN OPEN AND CLOSED TEMPORALITY WITH A VAC PACK. SHE WAS TREATED IN ICU. AFTER SOME DAYS HER ABDOMEN WAS CLOSED. PATIENT INJURED, EXTENSION OF OP BY MORE THAN 30 MINUTES, NO BLOOD LOSS, NO EXTENSION OF INCISION, NO CHANGE OF OP, NO LOSS OR DAMAGE TO TISSUE. NO REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE STAPLING DEVICE. THE CONDITIONS OF THE PATIENT IS IMPROVING BUT SHE IS STILL HOSPITALIZED. SHE WILL NEED ANOTHER OPERATION DUE TO THE STOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410052 GIA 80-3.8 SINGLE USE LOADING UNIT DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO P4A0795X

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other