BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER

    MDR report key: 1122051 · Received August 14, 2008

    Report

    Report Number
    3005075853-2008-01219
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Report Date
    August 5, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON RESECTION PROCEDURE ONLY ONE SIDE OF THE STAPELINE DEPLOYED AND THE OTHERSIDE DID NOT DEPLOY FORMED STAPLES. THEY HANDSEWED THE SIDE THAT DID NOT DEPLOY FORMED STAPLES. THE CASE WAS EXTENDED TWO AND ONE HALF HOURS, DUE TO THE MALFORMED STAPLE CLEANUP, AND SUTURING THAT WAS REQUIRED. THE DEVICE IS BEING HELD BY THE FACILITY. THE PT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR STAPLER GDW ETHICON ENDO-SURGERY, LLC. NA Y44654

    Patients

    Seq Age Sex Outcome Treatment
    1