BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 4

    MDR report key: 1162307 · Received September 8, 2008

    Report

    Report Number
    3005075853-2008-01574
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 18, 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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 09/08/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS THAT DURING A LAP GASTRECTOMY PROCEDURE, THE STAPLES DID NOT FORM WELL ON THE FIRST AND SECOND RELOADS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 4 GDW ETHICON ENDO-SURGERY, LLC. NA D4J00Y

    Patients

    Seq Age Sex Outcome Treatment
    1