BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 2

    MDR report key: 1250802 · Received December 2, 2008

    Report

    Report Number
    3005075853-2008-03369
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 28, 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

    DATE SENT: 12/02/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOIDECTOMY PROCEDURE, BLEEDING OCCURRED FROM THE END OF THE STAPLE LINE AFTER THE SURGEON RELEASED THE DEVICE. ONE STAPLE IN THE MIDDLE OF THE STAPLE LINE SEEMED TO COME OFF. UNK EXACTLY HOW MUCH BLOOD WAS LOST BUT IT WAS A LOW AMOUNT. THE DOCTOR CLAMPED THE TISSUE WITH FORCEPS AND THEN THE BLEED WAS STOPPED. CASE WAS COMPLETED WITH ADDITIONAL SUTURES. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 2 GDW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1