BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS STRAIGHT INTRALUMINAL STAPLER - 29MM

    MDR report key: 1459314 · Received May 21, 2009

    Report

    Report Number
    3005075853-2009-02977
    Event Type
    Malfunction
    Date Received
    May 21, 2009
    Report Date
    April 28, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 05/21/2009. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMA RESECTION PROCEDURE, THE DEVICE DID NOT STAPLE CORRECTLY. NO FURTHER INFO IS AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS STRAIGHT INTRALUMINAL STAPLER - 29MM GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1