BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER - 60 MM

    MDR report key: 1080469 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00413
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    March 20, 2008
    Report Date
    June 19, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 7/11/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE WAS USED TO STAPLE THE RECTUM. THE CIRCULAR STAPLER WAS INTRODUCED AND THE STAPLE LINE WAS DISRUPTED AND THE STAPLES WERE NOT FORMED. THE ANASTOMOSIS WAS HAND SUTURED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR STAPLER - 60 MM NONE GDW ETHICON ENDO-SURGERY, LLC NA E4K56D

    Patients

    Seq Age Sex Outcome Treatment
    1