BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 60-3.5 SINGLE USE STAPLER

    MDR report key: 1004740 · Received February 28, 2008

    Report

    Report Number
    2647580-2008-00105
    Event Type
    Injury
    Date Received
    February 28, 2008
    Date of Event
    December 28, 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 REPORT STATED MULTIPLE DEVICES WERE USED IN THE PROCEDURE BUT THEY WERE UNSURE WHICH STAPLE LINE THE ALLEGED LEAK OCCURRED FROM. THE PRODUCTS, LOT #S, EXPIRATION AND MANUFACTURING DATES ARE AS FOLLOWS: PRODUCTS: GIA038S AND GIA6038L, GIA 60-3.8 SINGLE USE STAPLER AND SULU LOT #S: P7J0001 AND P7K0351, EXPIRATION DATE: 9/30/2012 AND 10/31/2012, MANUFACTURE DATE: 09/2007 AND 10/2007

    Description of Event or Problem · 1

    PROCEDURE COLOSTOMY REVERSAL ACCORDING TO THE REPORTER: THE PATIENT WAS RETURNED TO SURGERY DUE TO A STAPLE LINE LEAK IN 2008. THE LEAK WAS FIXED WITH ADDITIONAL STAPLER DEVICES AND SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA 60-3.5 SINGLE USE STAPLER DISPOSABLE SURGICAL STAPLER GAG PONCE - USS P7K0625

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention