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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stapler, surgical
Definition A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
Product CodeGAG
Regulation Number 878.4740
Device Class 2


Premarket Reviews
ManufacturerDecision
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 81 81
2019 70 70
2020 47 47
2021 52 52
2022 47 47
2023 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Form Staple 45 45
Misfire 37 37
Failure to Fire 28 28
Mechanical Jam 26 26
Break 22 22
Adverse Event Without Identified Device or Use Problem 21 21
Mechanical Problem 20 20
Firing Problem 16 16
Difficult to Open or Close 15 15
Defective Device 9 9
Insufficient Information 9 9
Physical Resistance/Sticking 8 8
Therapeutic or Diagnostic Output Failure 7 7
Device Operates Differently Than Expected 6 6
Difficult to Remove 6 6
Product Quality Problem 5 5
Device Appears to Trigger Rejection 5 5
Detachment of Device or Device Component 5 5
Appropriate Term/Code Not Available 5 5
Material Twisted/Bent 4 4
Patient Device Interaction Problem 4 4
Activation, Positioning or Separation Problem 4 4
Device Dislodged or Dislocated 4 4
Use of Device Problem 4 4
Failure To Adhere Or Bond 4 4
Entrapment of Device 4 4
Loose or Intermittent Connection 3 3
Nonstandard Device 3 3
Failure to Cut 3 3
Noise, Audible 3 3
Output Problem 3 3
Mechanics Altered 2 2
Activation Problem 2 2
Device Inoperable 2 2
Patient-Device Incompatibility 2 2
Leak/Splash 2 2
Misassembled 2 2
Fluid/Blood Leak 2 2
Bent 2 2
Detachment Of Device Component 2 2
Improper or Incorrect Procedure or Method 2 2
Retraction Problem 2 2
Self-Activation or Keying 2 2
Tear, Rip or Hole in Device Packaging 2 2
Dull, Blunt 1 1
Failure to Calibrate 1 1
Structural Problem 1 1
Failure to Align 1 1
Separation Failure 1 1
Material Separation 1 1
Device Slipped 1 1
Unexpected Therapeutic Results 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Failure to Cycle 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1
Partial Blockage 1 1
Fracture 1 1
Poor Quality Image 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Off-Label Use 1 1
Deformation Due to Compressive Stress 1 1
Connection Problem 1 1
Malposition of Device 1 1
Failure to Auto Stop 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Protrusion/Extrusion 1 1
Device-Device Incompatibility 1 1
Migration 1 1
Ejection Problem 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 64 64
No Clinical Signs, Symptoms or Conditions 41 41
Insufficient Information 37 37
Wound Dehiscence 29 29
Failure to Anastomose 28 28
No Information 21 22
No Consequences Or Impact To Patient 19 19
Hemorrhage/Bleeding 14 14
Tissue Damage 8 8
Inflammation 8 8
No Code Available 8 8
Death 7 7
Patient Problem/Medical Problem 6 6
Post Operative Wound Infection 6 6
Blood Loss 6 6
Abdominal Pain 5 5
Abscess 5 5
Unspecified Infection 4 4
Pain 4 4
Sepsis 4 4
No Patient Involvement 4 4
Rectal Anastomotic Leakage 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Obstruction/Occlusion 3 3
Perforation 3 3
Hypersensitivity/Allergic reaction 3 3
Fever 3 3
Cellulitis 2 2
Purulent Discharge 2 2
Infiltration into Tissue 2 2
Laceration(s) 2 2
Injury 2 2
Tachycardia 2 2
Bronchial Hemorrhage 2 2
Bowel Perforation 2 2
Device Embedded In Tissue or Plaque 2 2
Vascular Dissection 1 1
Abdominal Distention 1 1
Intra-Abdominal Hemorrhage 1 1
Cancer 1 1
Blister 1 1
Implant Pain 1 1
Skin Irritation 1 1
Hernia 1 1
Complaint, Ill-Defined 1 1
Nausea 1 1
Necrosis 1 1
Pneumothorax 1 1
Dyspnea 1 1
Exsanguination 1 1
Adhesion(s) 1 1
Aspiration/Inhalation 1 1
Cyst(s) 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN LLC II Oct-04-2018
2 Covidien, LP II Jul-01-2022
3 Intuitive Surgical, Inc. II May-05-2020
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