BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP

    MDR report key: 2210030 · Received August 2, 2011

    Report

    Report Number
    3006451981-2011-00012
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC SIGMOIDECTOMY. ACCORDING TO THE RPTR: AFTER THE ANASTOMOSIS, THE DEVICE COULD NOT BE REMOVED. AN ADDITIONAL 2 CM RESECTION OF TISSUE WAS PERFORMED AND RE-ANASTOMOSIS WAS DONE WITH A DIFFERENT DEVICE. NO BLEEDING OCCURRED. NOTHING FELL INTO THE PT CAVITY. NO TISSUE WAS DAMAGED. OPERATIVE TIME WAS EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN MEDICAL PRODUCTS S1AC022

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability