BEUDAMED
    FDA Adverse Event Injury Summary report: N

    45MM ARTICING LNR CUTR/BLUE RLD

    MDR report key: 656247 · Received December 21, 2005

    Report

    Report Number
    1527736-2005-06273
    Event Type
    Injury
    Date Received
    December 21, 2005
    Date of Event
    December 15, 2005
    Report Date
    December 19, 2005
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE PRESENT ON THE DEVICE, HOWEVER FOUR CARTRIDGES PRESENT ON THE DEVICE, HOWEVER FOUR CARTRIDGES WERE RECEIVED LOOSE INSIDE THE BAG, FULLY FIRED AND WITH NO DAMAGED TO THE SPRING CARTRIDGE LOCKOUT. THE DEVICE WAS TESTED FOR FUNCTIONALLY WITH A TEST CARTRIDGE AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITH OUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. 510(K) # IS K020779.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, THE PATIENT'S BRONCHI WERE TORN. THE PROCEDURE WAS COMPLETED BY HAND-SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICING LNR CUTR/BLUE RLD ENDO LINEAR CUTTERS - ETS45MM GCJ ETHICON ENDO-SURGERY, INC. NA Y4549G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention