BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITE RELOAD FOR ECHELON 60

    MDR report key: 2990010 · Received March 5, 2013

    Report

    Report Number
    3005075853-2013-01035
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    February 8, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLECTOMY PROCEDURE, THERE WAS A POST OP HEMORRHAGE. THE PATIENT HAD UNDERGONE A COLECTOMY (DATE UNKNOWN). AFTER THIS SURGERY, BLEEDING OCCURRED. THE SURGEON HAD TO PERFORM ANOTHER SURGERY AND IDENTIFIED THE ORIGIN OF THE BLEEDING AS THE MESENTERIC ARTERY (SUTURED DURING THE COLECTOMY BY A CARTRIDGE). BLEEDING OF THE STAPLE LINE AFTER USING A CARTRIDGE OCCURRED SEVERAL TIMES AFTER THIS CASE. ONE RELOAD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93031 WHITE RELOAD FOR ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4A58H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention