BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER

    MDR report key: 1831660 · Received August 16, 2007

    Report

    Report Number
    1527736-2007-05459
    Event Type
    Malfunction
    Date Received
    August 16, 2007
    Date of Event
    July 19, 2007
    Report Date
    August 10, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BOWEL RESECTION PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR STAPLER GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4G629

    Patients

    Seq Age Sex Outcome Treatment
    1