BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1030045 · Received April 15, 2008

    Report

    Report Number
    1219930-2008-00298
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 25, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 04/15/2008.

    Description of Event or Problem · 1

    PROCEDURE: WEDGE RESECTION. ACCORDING TO THE RPTR: THE JAWS LOCKED ON TISSUE. THE DR STAPLED AROUND THE CARTRIDGE AND REMOVED A SMALL PIECE OF TISSUE AND THE CARTRIDGE. NO BLOOD LOSS, EXTRA OR TIME WAS 10 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST SURGICAL STAPLING DEVICE GAG NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention