BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURVED EEA 28 STAPLER

    MDR report key: 2250023 · Received September 9, 2011

    Report

    Report Number
    3006451981-2011-00015
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: ON (B)(6) 2011, (B)(6) USED A CEEA28 TO OPERATE A GASTRO-JEJUNO-ANASTOMOSIS FOR A RADICAL OPERATION OF GASTRIC CARDIA UNDER GENERAL ANESTHESIA. DURING THE ANASTOMOSIS, THE SURGEON FIRED A CEEA28 STAPLER AND FOUND THAT SOME OF THE STAPES WERE NOT FORMATTED FULLY AS A B SHAPE. THEN HE REMOVED THE STAPLES AND USED SUTURE TO FINISH THE SURGERY. THE PATIENT RECOVERED WELL. MEDICAL INTERVENTION WAS REQUIRED; SURGERY TIME WAS EXTENDED BY 30MINS OR MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVED EEA 28 STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN MEDICAL PRODUCTS S1BD007

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other