BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 953079 · Received November 16, 2007

    Report

    Report Number
    1527736-2007-07784
    Event Type
    Injury
    Date Received
    November 16, 2007
    Date of Event
    October 25, 2007
    Report Date
    October 26, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 11/16/2007. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, THERE WERE NO STAPLES IN THE DEVICE. THE CASE LASTED THREE HOURS LONGER THAN NORMAL. SURGEON DID COLO-ANAL ANASTOMOSIS BY HAND SEWING TO FINISH THE CASE. PATIENT NEEDED AN ILEOSTOMY AND A LONGER HOSPITAL STAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R