BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC LINEAR CUTTER, 45MM REGULAR

    MDR report key: 1210265 · Received October 21, 2008

    Report

    Report Number
    3005075853-2008-02485
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, THE DEVICE WAS USED TO SEPARATE THE LUNG AND ALTHOUGH THE STAPLES WERE FULLY FORMED AT THE SAMPLE, THERE WERE NO STAPLES FORMED AT THE CENTRAL PART. ADDITIONAL SUTURING WAS PERFORMED AND THERE WAS NO PROBLEM WITH THE SECOND FIRING. THE DOCTOR CONFIRMED THE FIRST CARTRIDGE HAD THE REMAINED UNFORMED STAPLES IN THE STAPLE POCKET AT TWO LINES OF ONE SIDE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC LINEAR CUTTER, 45MM REGULAR GDW ETHICON ENDO-SURGERY, LLC NA D4JK35

    Patients

    Seq Age Sex Outcome Treatment
    1