BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2900224 · Received January 7, 2013

    Report

    Report Number
    3005075853-2013-00107
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A RIGHT HEMICOLECTOMY PROCEDURE PERFORMED ON (B)(6) 2012 THE PATIENT EXPERIENCED EXCESSIVE BLEEDING WITHIN A 24 HOUR PERIOD POST-OPERATIVELY. A GIA STAPLER WAS ALSO USED DURING PROCEDURE. PATIENT REQUIRED BLOOD TRANSFUSION POST OPERATIVELY. DEVICE WAS DISCARDED. THERE WAS NO OTHER REPORTED PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6545 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention