Contains Nonbinding Recommendations 
 
 
Surgical Staplers and Staples for 
Internal Use - Labeling 
Recommendations 
______________________________________________________________________________ 
Guidance for Industry and 
Food and Drug Administration Staff 
 
Document issued on October 8, 2021. 
 
The draft of this document was issued on April 24, 2019. 
 
For questions about this document, contact OHT4: Office of Surgical and Infection Control 
Devices/DHT4B: Division of Infection Control and Plastic Surgery Devices at 301-796-6970. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
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  Contains Nonbinding Recommendations 
 
 
Preface 
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2019-D-1262. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
 
Additional Copies 
 
Additional copies are available from the Internet.  You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidanc e. Please include the document 
number 18013 and complete title of the guidance in the request.  
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  Contains Nonbinding Recommendations 
 
 
Surgical Staplers and Staples for 
Internal Use - Labeling 
Recommendations 
______________________________________________________________________________ 
Guidance for Industry and 
Food and Drug Administration Staff 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page.  
I.  Introduction 
 
The Food and Drug Administration (FDA) is issuing this guidance to provide labeling 
recommendations for surgical staplers and staples for internal use. These labeling 
recommendations are being issued because malfunctions and misuse associated with these 
devices have resulted in serious adverse events, including deaths.1  
 
FDA believes that the labeling recommendations in this guidance would help promote the safe 
and effective use of surgical staplers and staples for internal use by helping manufacturers 
develop labeling with information about specific risks, limitations, and directions for use of the 
device.2  
 
The contents of this document do not have the force and effect of law and are not meant to bind the 
public in any way, unless specifically incorporated into a contract. This document is intended only to 
provide clarity to the public regarding existing requirements under the law. FDA guidance 
documents, including this guidance, should be viewed only as recommendations, unless specific 
regulatory or statutory requirements are cited. The use of the word should in Agency guidance 
means that something is suggested or recommended, but not required.  
 
 
1 See e.g., FDA Manufacturer and User Facility Device Experience (MAUDE) Database, search of the product 
codes GDW and GAG from January 1, 2011  March 31, 2018.  
2 In addition, FDA has finalized the reclassification of surgical staplers for internal use from class I to class II with 
special controls. See the final order Reclassification of Certain Surgical Staplers issued October 8, 2021 (86 FR 
56195) available at https://www.federalregister.gov/d/2021-22041.  
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II.  Background 
 
Surgical staplers for internal use are specialized prescription devices used to deliver compatible 
staples to internal tissues during surgery for resection, transection, and creating anastomoses. 
Surgical staplers and staples for internal use may be indicated for use in a wide range of surgical 
applications, including but not limited to gastrointestinal, gynecologic, and thoracic surgery. 
 
FDA developed the draft of this guidance because we had become aware of a large number of 
adverse events associated with use of both surgical staplers and staples for internal use. Between 
January 2011  March 2018, FDA received over 41,000 adverse event reports associated with 
surgical staplers and staples for internal use, including over 360 deaths associated with the use of 
surgical staplers and staples for internal use.3 Some of the most commonly reported problems in 
these adverse event reports include an opening of the staple line or malformation of staples, 
misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples (e.g., 
user applying staples to the wrong tissue or applying staples of the wrong size to the tissue).4,5  
Although the majority of the adverse events were reported under product code GDW (Staple, 
Implantable), FDA believes that many of the problems identified in these reports can be 
primarily attributed to surgical staplers for internal use, since proper staple formation is largely 
contingent on proper function and use of the stapler.7  
 
Stapler and/or staple malfunctions may result in prolonged surgical procedures or unplanned, 
additional surgical interventions, and other complications such as bleeding, sepsis, fistula 
formation, tearing of internal tissues and organs, and death. Common causes for complications 
also include the use of incorrectly sized staples for the tissue, incorrect use of the device by the 
user and improper use of the device for the condition of the patients tissues, which may result in 
reoperation or prolonged hospitalization.6 For example, an early postoperative anastomotic leak 
due to such device issues may result in a septic patient with peritonitis, requiring immediate 
surgery with diversion of stool into a stoma. Minor or delayed anastomotic leaks due to such 
device issues may result in an intra-abdominal abscess requiring surgical or other invasive 
drainage procedures, temporary diversion of stool, and prolonged intravenous nutrition. These 
complications commonly result in prolonged hospital stays.7 
 
 
3 FDA Manufacturer and User Facility Device Experience (MAUDE) Database, search of the product codes GDW 
and GAG from January 1, 2011  March 31, 2018.  
4 U.S. Food and Drug Administration, Safe Use of Surgical Staplers and Staples  Letter to Health Care Providers, 
March 8, 2019, available at https://www.fda.gov/medical-devices/letters-health-care-providers/safe-use-surgical-
staplers-and-staples-letter-health-care-providers.  
5 84 FR 17116 (See https://www.federalregister.gov/documents/2019/04/24/2019-08260/general-and-plastic-
surgery-devices-reclassification-of-certain-surgical-staplers). 
6 Checkan E, Whelan RL. Surgical stapling device-tissue interactions: what surgeons need to know to improve 
patient outcomes. Med Devices (Auckl). 2014; 7:305-318.  
7 Betzold R, Laryea JA. Staple Line/Anastomotic Reinforcement and Other Adjuncts: Do They Make a Difference? 
Clin Colon Rectal Surg. 2014 Dec; 27(4): 156-161.  
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Both device misuse and device malfunctions are root causes of these adverse events.8 Device 
misuse may be exacerbated by inadequate instructions for use, and insufficient warnings or 
precautions in the device labeling.9 FDA believes that these problems will be mitigated by 
providing specific information about the risks, limitations, and directions for use in the labeling 
for the surgical staplers and staples for internal use. The inclusion of such information should 
also be helpful in developing labeling with adequate information for use under 21 CFR 801.109. 
For example, FDA believes the inclusion of important device technical characteristics and 
performance parameters in the labeling would inform end users on device limitations, thereby 
increasing the likelihood of appropriate device use and mitigate against device malfunctions. For 
these reasons, FDA recommends that the labeling of surgical staplers and staples for internal use 
contain the warnings, contraindications, instructions, and usage information identified below.   
III.  Scope 
 
The scope of this document is limited to surgical staplers and staples for internal use with 
product codes listed in the table below:10,11 
 
Product Code  Regulation Number  Name 
GAG  21 CFR 878.4740  Stapler, Surgical 
GDW  21 CFR 878.4750  Staple, Implantable 
NLL  21 CFR 878.4750  Staple, Implantable, Reprocessed 
NAY  21 CFR 876.1500  System, Surgical, Computer Controlled 
Instrument12 
IV.  Labeling Recommendations 
 
Accurate labeling with clear communication will help mitigate the safety issues associated with 
surgical staplers and staples for internal use and help manufacturers develop labeling with 
adequate information. Based on FDAs review of the adverse event reports discussed above, the 
labeling for these devices may not contain all important information about the risks, limitations, 
and directions for use of the device, and therefore, may not contain adequate information for use 
 
8  Brown SL, Woo EK. Surgical stapler-associated fatalities and adverse events reported to the Food and Drug 
Administration. J Am Coll Surg. 2004; 199(3):374-381.  
9 Swayze S, Rich S. Promoting Safe Use of Medical Devices. The Online Journal of Issues in Nursing. 2011; 17(1).  
10 FDA has finalized the reclassification of surgical staplers for internal use from class I to class II with special 
controls that include specific labeling requirements cited in this section. See the final order Reclassification of 
Certain Surgical Staplers issued October 8, 2021 (86 FR 56195) available at 
https://www.federalregister.gov/d/2021-22041.  
11 Although the special controls under 21 CFR 878.4740 do not apply to product codes GDW, NLL, and NAY, the 
recommendations in this guidance are applicable to all product codes identified in this table.  
12 An analysis of adverse events for robotic surgical staplers for internal use (i.e., robotic staplers), which are class 
II devices and assigned the product code NAY, indicate that the same risks apply to robotic staplers as surgical 
staplers for internal use. Therefore, FDA believes that the labeling recommendations in this guidance should also 
apply to robotic staplers.  
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under 21 CFR 801.109.13,14 FDA believes that accurate product labeling is important to make 
device users aware of the risks, limitations, and directions for use of surgical staplers and staples 
for internal use. As such, the contraindications, warnings, directions for use, technical 
characteristics and performance parameters identified below should help mitigate the safety 
issues associated with surgical staplers and staples for internal use and help manufacturers 
develop labeling with adequate information for use.15  
 
In addition, FDA has established special controls that require specific labeling for surgical 
staplers for internal use (21 CFR 878.4740(b)(2)(ix) and 21 CFR 878.4740(b)(2)(x)). To help 
manufacturers develop labeling that complies with the required special controls (shown in italic 
font) and to mitigate the safety issues identified in surgical staplers for internal use, FDA is 
providing the following labeling recommendations. These recommendations are intended to 
supplement, and not replace, good clinical judgement. Although the special controls identified 
herein are only required for surgical staplers for internal use under 21 CFR 878.4740, the 
recommendations in this guidance are applicable to all surgical staplers and staples for internal 
use identified in Section III (Scope). We intend for the recommendations below to supplement 
and enhance the information that is often already included in labeling for these device types.  
  Contraindications 
 
Special control 21 CFR 878.4740(b)(2)(ix)(A) states:  
 
Unless data demonstrates the safety of doing so, contraindications must be 
identified regarding use of the device on tissues for which the risk of stapling 
outweighs any reasonably foreseeable benefit due to known complications, 
including the stapling of tissues that are necrotic, friable, or have altered 
integrity.  
 
Recommendation: A statement noting that the device should not be used to staple 
tissues that are necrotic, friable, or have altered integrity, e.g., ischemic or 
edematous tissues  
  Warnings 
 
Special control 21 CFR 878.4740(b)(2)(ix)(B) states:  
 
 
13 See 21 CFR 801.109 for a complete list of the required information in device labeling. There are also other 
labeling requirements under the regulations and the Federal Food, Drug, and Cosmetic Act (FD&C Act), e.g., 
section 502(f)(2) of the FD&C Act. 
14 Moreover, a device shall be deemed misbranded if, among other things: its labeling is false or misleading or its 
labeling does not contain adequate warnings (see sections 502(a), 201(n), and 502(f) of the FD&C Act). 
15 While the recommendations are intended to help manufacturers develop labeling that contains adequate 
information for use under 21 CFR 801.109, the specific information required in device labeling to comply with this 
provision and other provisions in the regulations and the FD&C Act depends on the facts and circumstances 
regarding the particular device (e.g., the design of the device). 
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Unless available information demonstrates that the specific warnings do not 
apply, the labeling must provide appropriate warnings regarding how to avoid 
known hazards associated with device use including: 
 
  Avoidance of use of the stapler to staple tissue outside of the labeled limits for 
maximum and minimum tissue thickness (21 CFR 878.4740(b)(2)(ix)(B)(i));  
 
Recommendation: A statement noting that the device should not be used to 
staple tissue outside of the labeled limits for maximum and minimum tissue 
thickness 
 
  Avoidance of obstructions to the creation of the staple line and the unintended 
stapling of other anatomic structures (21 CFR 878.4740(b)(2)(ix)(B)(ii));   
 
Recommendations: 
 
  A statement to visually inspect prior to firing for inclusion of unintended 
anatomic structures within the staple line 
  A statement to ensure that no obstructions, such as clips, are incorporated 
into the instrument jaws when positioning the stapler on the application 
site, and that firing over an obstruction may result in incomplete cutting 
action and/or improperly formed staples  
 
  Avoidance of clamping and unclamping of delicate tissue structures to prevent 
tissue damage (21 CFR 878.4740(b)(2)(ix)(B)(iii));    
 
Recommendation: A statement that clamping and unclamping of delicate 
structures, such as venous structures and bile ducts, may result in damage to 
tissue irrespective of stapler firing 
 
  Avoidance of use of the stapler on the aorta (21 CFR 
878.4740(b)(2)(ix)(B)(iv));  
 
Recommendation: A statement to avoid use of the stapler on the aorta 
 
  Establishing proximal control of blood vessels prior to stapling where 
practical and methods of blood vessel control in the event of stapler failure 
(21 CFR 878.4740(b)(2)(ix)(B)(v));   
 
Recommendation: A statement that, where practical, proximal control of 
blood vessels is recommended prior to stapling, and that surgeons should have 
methods of blood vessel control in place in the event of stapler failure 
 
  Ensuring stapler compatibility with staples (21 CFR 
878.4740(b)(2)(ix)(B)(vi)); and 
 
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Recommendation: A statement to ensure that the staples are compatible with 
the stapler 
 
  Risks specifically associated with the crossing of staple lines (21 CFR 
878.4740(b)(2)(ix)(B)(vii)).  
   
Recommendation: A statement that there is a risk of increased leak rates when 
staple lines are crossed, even if there may be clinical circumstances when a 
surgeon may deem it necessary or appropriate to do so  
  Directions For Use 
 
Consistent with the special controls identified below, the labeling of the device 
must include the following: 
 
  Specific user instructions for proper device use including measures associated 
with the prevention of device malfunction, and evaluation of the 
appropriateness of the target tissue for stapling (21 CFR 
878.4740(b)(2)(ix)(C)).  
 
Recommendation: FDA recommends that the product labeling for surgical 
staplers and staples for internal use contain clear instructions for use 
addressing the following: 
 
  The procedures for proper cartridge installation, removal/exchange, and 
preventing and mitigating the effects of the stapler jamming, locking, 
misfiring, or otherwise malfunctioning. Manufacturers should consider use 
of diagrams to help illustrate these procedures, when appropriate. 
  The procedures for determining that a tissue is appropriate for stapling  
  The time required for adequate pre-firing compression  
 
  Validated methods and instructions for reprocessing of any reusable device 
components (21 CFR 878.4740(b)(2)(ix)(H)).  
 
Recommendation: For recommendations regarding the development and 
validation of reprocessing instructions in your proposed device labeling, refer 
to FDAs guidance Reprocessing Medical Devices in Health Care Settings: 
Validation Methods and Labeling.16  
 
  An expiration date/shelf life (21 CFR 878.4740(b)(2)(ix)(I)).  
 
 
16 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-
health-care-settings-validation-methods-and-labeling. 
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  Technical Characteristics and Performance Parameters 
 
Consistent with the special controls identified below, the labeling of the device 
must include the following: 
 
  List of staples with which the stapler has been demonstrated to be 
compatible (21 CFR 878.4740(b)(2)(ix)(D)). 
 
Recommendation: Models of staples (e.g., identified by manufacturer, trade 
name, and model number) with which the stapler has been demonstrated to 
be compatible. (This need not be an exhaustive list of compatible staples, 
but should include at least one compatible model. The list should not 
preclude the use of staples that have independently demonstrated 
compatibility with the identified stapler.) 
 
  Identification of key performance parameters and technical 
characteristics of the stapler and the compatible staples needed for safe 
use of the device (21 CFR 878.4740(b)(2)(ix)(E)). 
 
Recommendation: In identifying the key technical characteristics and 
performance parameters, the product labeling should do so clearly and 
should include the following, as applicable:  
 
  Maximum and minimum tissue thickness that can be comfortably 
compressed for each staple type based on their open and closed staple 
heights 
  Angle(s) of articulation (manufacturers should consider use of 
diagrams to illustrate angles of articulation when possible)  
  Cartridge size 
  Maximum number of consecutive firings the stapler can perform 
  Staple line reinforcing products with which the stapler is compatible 
(or include statement if no evaluation with staple line reinforcing 
materials has been completed) 
 
  Information regarding tissues on which the stapler is intended to be used 
(21 CFR 878.4740(b)(2)(ix)(F)). 
 
Recommendation: Examples of types of tissues on which the stapler and 
staples may be used 
 
  Identification of safety mechanisms of the stapler (21 CFR 
878.4740(b)(2)(ix)(G)). 
 
Recommendation: Safety mechanism(s) for tissue thickness (e.g., 
identification of whether a stapler has built-in methods for assessing 
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and/or limiting operation when the underlying tissues are outside of a 
predefined range, etc.) 
 
  Package labels must include critical information and technical 
characteristics necessary for proper device selection (21 CFR 
878.4740(b)(2)(x)). 
 
Recommendation:  Users should be able to easily look at the package label 
for surgical staplers for internal use and obtain critical information 
necessary for proper device selection.  
 
  For manual and powered linear cutting staplers for open/endoscopic 
surgery, and transverse approximator non-cutting open staplers, this 
information should include the following, as appropriate: 
 
  Cartridge color(s) and corresponding open and closed staple 
heights and intended tissues for approximation 
  Cartridge size 
  Shaft length 
  Tissue gap or distal jaw opening 
  Angle(s) of articulation 
  Total number of staple rows per cartridge 
  Staple pattern(s)  
  Maximum number of reloads 
  Pre-fire compression time  
  Number of incremental firings (e.g. trigger actualizations) 
required to complete a staple line 
  Safety mechanism(s) for tissue thickness  
  Type of ready-to-fire indicator (e.g., green window or 
illuminated LED)  
  Identification of compatible trocar sizes 
 
  For manual and powered circular staplers for open/endoscopic surgery, 
this information should include the following, as appropriate: 
 
  Cartridge color(s) and corresponding open and closed staple 
heights and intended tissues for approximation 
  Cartridge size (i.e., diameter)  
  Total number of staple rows per cartridge 
  Staple pattern(s) 
  Pre-fire compression time 
  Turns of handle knob counterclockwise required to remove the 
stapler after firing 
  Safety mechanism(s) for tissue thickness 
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  Type of ready-to-fire indicator (e.g., green window or 
illuminated LED)  
 
Additionally, the package label for surgical staples for internal use should 
clearly identify the following technical characteristics and performance 
parameters:  
 
  Cartridge color(s) and corresponding open and closed staple 
height(s) and intended tissues for approximation  
  Number of staple rows per cartridge  
  Models of staplers (e.g., identified by manufacturer, trade 
name, model number) with which the staple has been 
demonstrated to be compatible 
 
Please see Appendix A for examples of package labels containing 
recommended technical characteristics and performance parameters for 
surgical staplers and staples for internal use. 
 
Manufacturers of surgical staplers for internal use under 21 CFR 878.4740 should refer to 
Section V (Implementation Strategy) of FDAs Final Order, General and Plastic Surgery 
Devices; Reclassification of Certain Surgical Staplers17 for information on dates when FDA 
intends to enforce compliance with the Final Order.  
 
FDA also encourages manufacturers of all other surgical staplers and staples for internal use 
identified in Section III (Scope) (i.e., those that do not fall under 21 CFR 878.4740) to make any 
appropriate changes to their product labeling in a timely manner. FDA recommends that such 
labeling changes be made within 180 days from the publication of this document.  
 
Manufacturers should evaluate their changes according to FDAs guidance Deciding When to 
Submit a 510(k) for a Change to an Existing Device18 to determine whether a new 510(k) is 
 
required for changes to an existing device. 
 
17 See the final order Reclassification of Certain Surgical Staplers issued October 8, 2021 (86 FR 56195) available 
at https://www.federalregister.gov/d/2021-22041.  
18 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-
change-existing-device.  
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Appendix A.  Examples of Package Labels 
 
This section provides example package labels for different types of surgical staplers and staples 
for internal use containing the technical characteristics and performance parameters 
recommended for the package label, as described in Section IV.D.  
 
Table 1. Example package label for an endoscopic linear cutting stapler.  
 
Endoscopic Linear Cutting Stapler 
Cartridge color(s) and corresponding open  Blue (3.5 mm open; 1.5 closed)   bowel 
and closed staple heights and intended tissues  White (2.5 mm open; 1.0 closed)  
for approximation  vascular 
Green (4.1 mm open; 2.0 closed)  
stomach  
Cartridge size  45 mm 
Shaft length  38 cm  
Tissue gap or distal jaw opening  12 mm 
Angle(s) of articulation   90 degrees, 45 degrees, and 30 degrees in 
each set direction  
Total number of staple rows per cartridge  Blue  4 or 6  
White  4 
Green  6 
Staple pattern(s)  Staggered, non-staggered 
Maximum number of reloads    15 
Pre-fire compression time  Blue: 15  20 seconds 
White: 5 - 10 seconds 
Green: 20  30 seconds 
Number of incremental firings (e.g., trigger  3  
actualizations) required to complete a staple   
line 
Safety mechanism(s) for tissue thickness  Lock-out, color firing zone  
Type of ready-to-fire indicator   Illuminated LED 
Compatible trocar sizes  5, 8, 12, and 15 mm 
 
 
 
 
 
 
 
 
 
 
 
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Table 2. Example package label for a circular stapler  
for open/endoscopic surgery. 
 
Circular Stapler for Open/Endoscopic Surgery 
Cartridge color(s) and corresponding open  Purple (3.5 mm open; 1.5 closed)  bowel 
and closed staple heights and intended tissues   
for approximation 
Cartridges size (i.e., diameter)  31 mm  
Total number of staple rows per cartridge  2 
Staple pattern(s)  Staggered, non-staggered 
Pre-fire compression time  Purple: 1  2 minutes 
Turns of handle knob counterclockwise  112 turn   
required to remove the stapler after firing 
Safety mechanism(s) for tissue thickness  Lock-out, color firing zone  
Type of ready-to-fire indicator   Illuminated LED 
 
 
Table 3. Example package label for surgical staples 
 
Surgical Staples  
Cartridge color(s) and corresponding open  White (2.5 mm open; 1.0 mm closed)  
and closed staple heights and intended tissues  vascular 
for approximation   
Number of staple rows per cartridge  2 
Models of staplers (identified by  ABC Endoscopic Linear Cutting Stapler 
manufacturer, trade name, model number)  (Model # XYZ)  
with which the staple has been demonstrated 
to be compatible 
 
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