BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS STRAIGHT STAPLER

    MDR report key: 1823618 · Received August 16, 2007

    Report

    Report Number
    1527736-2007-05428
    Event Type
    Malfunction
    Date Received
    August 16, 2007
    Date of Event
    August 3, 2007
    Report Date
    August 6, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 AFTER A GASTRECTOMY PROCEDURE, THERE WAS LEAKING FROM THE STAPLE LINE. ADDITIONAL SUTURING WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS STRAIGHT STAPLER GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1