BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1112603 · Received August 11, 2008

    Report

    Report Number
    3005075853-2008-01105
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOWER ANTERIOR RESECTION PROCEDURE, THE DEVICE SEALED THE PROXIMAL END, BUT NOT THE DISTAL. THE SURGEON USED SUTURING TO FINISH THE PROCEDURE. THE PROCEDURE WAS EXTENDED BY 180 MINS. PT'S POST-OP CARE WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER GDW ETHICON ENDO-SURGERY, LLC NA D4J071

    Patients

    Seq Age Sex Outcome Treatment
    1