BEUDAMED
    FDA Adverse Event Injury Summary report: N

    60-3.5 SINGL USE STAPLER

    MDR report key: 1004738 · Received February 28, 2008

    Report

    Report Number
    2647580-2008-00103
    Event Type
    Injury
    Date Received
    February 28, 2008
    Date of Event
    September 4, 2007
    Report Date
    February 7, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER STATED MULTIPLE DEVICES WERE USED IN THE PROCEDURE BUT THEY WHICH STAPLE LINE THE ALLEGED LEAK OCCURRED FROM. THE PRODUCTS, LOT #S, EXPIRATION AND MANUFACTURING DATES ARE AS FOLLOWS BELOW: PRODUCTS: GIA6038S(1) AND GIA6038L(2), GIA 60-3.8 SINGLE USE STAPLER AND SULU LOT#S: P7F0939, P7B0108 AND P7C0568 EXPIRATION DATE: 6/30/2012, 2/29/2012 AND 3/31/2012 MANUFACTURE DATE: 06/2007, 02/2007 AND 03/2007.

    Description of Event or Problem · 1

    PROCEDURE: PROCEDURE: LAP ASSISTED ILEOCOLIC BIOPSY. ACCORDING TO THE REPORTER: THE PATIENT WAS RETURNED TO SURGERY IN 2007 DUE TO THE STAPLE LINE LEAK. THIS WAS FIXED WITH ADDITIONAL STAPLER DEVICES. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 60-3.5 SINGL USE STAPLER DISPOSABLE SURGICAL STAPLER GAG PONCE - USS TA6035S P7E0778

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention