BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC LINEAR CUTTER, 45MM REGULAR

    MDR report key: 1821109 · Received August 9, 2007

    Report

    Report Number
    1527736-2007-05260
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE THE DEVICE FIRED AN INCOMPLETE STAPLE LINE. THE SITE USED A NEW INSTRUMENT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC LINEAR CUTTER, 45MM REGULAR GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4G56H

    Patients

    Seq Age Sex Outcome Treatment
    1