BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1821126 · Received August 9, 2007

    Report

    Report Number
    1527736-2007-05257
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Date of Event
    June 12, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VIDEO COLECTOMY PROCEDURE THE DEVICE DID NOT PERFORM THE ANASTOMOSIS DUE TO MALFORMED STAPLES. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4G761

    Patients

    Seq Age Sex Outcome Treatment
    1