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Date Issued: May 7, 2013
Audience: Healthcare professionals, especially surgical clinicians, hospital and ambulatory surgery center managers, operating room managers and inventory management personnel
Medical Specialty: General surgery; all surgical specialties
Device: Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads with lot number N3B0165LX
Purpose:
The FDA is issuing this communication to alert you about Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads that were labeled sterile but were stolen from the manufacturer prior to product sterilization.
Summary of Problem and Scope:
The FDA is issuing this communication to inform you that the Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads with lot number N3B0165LX were stolen from the manufacturer before they were sterilized. Although these devices were packaged and labeled as sterile, they are not sterile. The FDA is aware that some of these stolen and unsterile products have been offered for sale.
The Covidien surgical stapler reloads are used in abdominal, gynecologic, pediatric and thoracic surgery. The use of these non-sterile products could increase the risk of infection in surgical patients.
The only way to identify the stolen, unsterile products is to check the Reference Code and the Lot Number on every box of Covidien Surgical Stapler Reloads prior to use.
Recommendations/Actions:
Do not use Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads labeled with Reference Code 030458 and Lot number N3B0165LX
Check your current inventory to determine if you have the surgical stapler reloads with lot number N3B0165LX. If you have these products, quarantine them and contact Covidien at 1-800-522-0263, option 5, for more information.
Purchase products from trusted and reliable sources such as the manufacturer or authorized distributors, do not purchase these products from online auction sites
Contact the FDA Office of Criminal Investigation at 1-800-551-3989 or visit the OCI Web Site disclaimer icon if you have any information regarding these stolen devices
FDA Activities:
The FDA Office of Criminal Investigation is in contact with Covidien regarding this situation.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with these Surgical Stapler Reloads, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.
To help us learn as much as possible about the adverse events associated with the Surgical Stapler Reloads, please include the following information in your reports, if available:
Product Name
Lot Number
Manufacturer
Relevant events prior and subsequent to the referenced problem
Concomitant medical products
Details of the adverse event and medical intervention (if required)
Contact Information
If you have questions about the Covidien Surgical Stapler Reloads, contact Covidien at 1-800-522-0263, option 5 for more information.
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at industry.devices@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
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