BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 2973501 · Received February 15, 2013

    Report

    Report Number
    2647580-2013-00079
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 18, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HEMICOLECTOMY. A PROCEDURE: HEMI COLECTOMY. ACCORDING TO THE REPORTER: ON (B)(6) 2013, A HEMI COLECTOMY WITH AN EEA31 INSTRUMENT WAS PERFORMED WITHOUT COMPLICATIONS. NO INJURIES TO THE PATIENT. NO COMPLICATIONS. NO INJURIES TO THE PATIENT. NO EXTENSION OF THE SURGERY TIME BY MORE THAN 30 MINUTES, NO BLOOD LOSS OF MORE THAN 250CC, NO UNANTICIPATED LOSS OR IRREVERSIBLE DAMAGE TO VASCULAR TISSUE, NOTHING FELL INTO THE PATIENT CAVITY. THE FOLLOWING DAY, (B)(6) 2013, THE PATIENT, DUE TO CRITICAL CONDITIONS (FECAL LOSS), WAS BROUGHT BACK TO THE OPERATING ROOM. THE SITUATION FOUND WAS BROUGHT BACK TO THE OPERATING ROOM. THE SITUATION FOUND WAS COMPLETE DEHISCENCE OF THE ANTERIOR WALL OF THE ANASTOMOSIS. A RE-OPERATION WITH AN EEA28 WAS PERFORMED (TOTAL COLECTOMY) WITHOUT COMPLICATIONS. NO REINFORCEMENT MATERIAL USED. CLINICAL SAMPLE IS NOT AVAILABLE SINCE IT WAS DISCARDED AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69520 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN, FORMERLY USSC P2C0676X

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other