BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR CUTTER RELOAD - THICK

    MDR report key: 1831628 · Received September 12, 2007

    Report

    Report Number
    1527736-2007-06012
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    August 28, 2007
    Report Date
    August 29, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS AN ISSUE WITH MALFORMED STAPLES ON A RELOAD. THE ANASTOMOSIS HAD TO BE HAND STITCHED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CUTTER RELOAD - THICK GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4GM7G

    Patients

    Seq Age Sex Outcome Treatment
    1