BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1911657 · Received December 1, 2010

    Report

    Report Number
    3005075853-2010-06767
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 12, 2010
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR RESECTION PROCEDURE, THE CONTOUR GUN WAS FIRED AND THE SURGEON REPORTS THAT THE DEVICE DID NOT STAPLE. THEY REPLACED THE CARTRIDGE IN THE SAME DEVICE AND FIRED AGAIN SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TAOD

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD # CR40B, LOT# G4RE2K