BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX 60 ENDO LINEAR CUTTER

    MDR report key: 921830 · Received October 2, 2007

    Report

    Report Number
    1527736-2007-06519
    Event Type
    Injury
    Date Received
    October 2, 2007
    Date of Event
    September 5, 2007
    Report Date
    September 5, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/02/2007. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HAND ASSISTED COLECTOMY PROCEDURE AFTER FIRING THE DEVICE IT WAS FOUND THAT THE DISTAL STAPLES DID NOT FORM. THE PROCEDURE WAS CONVERTED TO OPEN SINCE THE COLON WAS RESECTED BUT NOT STAPLED. THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX 60 ENDO LINEAR CUTTER GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4HU3K

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention