BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 4120820 · Received September 26, 2014

    Report

    Report Number
    2647580-2014-00808
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    July 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOIDECTOMY. ACCORDING TO THE REPORTER: THE STAPLE LINE (INTESTINAL TRACK) WAS BLEEDING TWO HOURS AFTER SURGERY. IT WAS NECESSARY TO USE 3 UNITS/BAGS OF BLOOD FOR A TRANSFUSION. THE EVENT DID NOT PROLONG THE HOSPITAL STAY. THE SURGICAL TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS UNANTICIPATED BLOOD LOSS OF 1,800 ML. THERE WAS NO REINFORCEMENT MATERIAL USED.

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOIDECTOMY. ACCORDING TO THE REPORTER: THE STAPLE LINE (INTESTINAL TRACK) WAS BLEEDING TWO HOURS AFTER SURGERY. IT WAS NECESSARY TO USE 3 UNITS/BAGS OF BLOOD FOR A TRANSFUSION, THE EVENT DID NOT PROLONG THE HOSPITAL STAY. THE SURGICAL TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS UNANTICIPATED BLOOD LOSS OF 1,800 ML. PATIENT WAS ON ANTIHYPERTENSIVE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601356 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA31 P3A0524X

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other