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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 4
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 2
LEXINGTON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 70 70
2020 47 47
2021 53 53
2022 48 48
2023 115 115
2024 596 596

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 220 220
Failure to Form Staple 163 163
Adverse Event Without Identified Device or Use Problem 114 114
Detachment of Device or Device Component 87 87
Misfire 77 77
Break 54 54
Mechanics Altered 47 47
Difficult to Remove 43 43
Failure to Align 32 32
Loss of or Failure to Bond 28 28
Human-Device Interface Problem 20 20
Firing Problem 20 20
Mechanical Problem 18 18
Insufficient Information 16 16
Material Twisted/Bent 16 16
Mechanical Jam 16 16
Expulsion 14 14
Entrapment of Device 14 14
Failure to Cut 14 14
Difficult to Open or Close 13 13
Noise, Audible 11 11
Device Slipped 11 11
Product Quality Problem 9 9
Physical Resistance/Sticking 8 8
Therapeutic or Diagnostic Output Failure 8 8
Retraction Problem 7 7
Defective Device 7 7
Protective Measures Problem 6 6
Patient Device Interaction Problem 5 5
Fail-Safe Problem 5 5
Device Appears to Trigger Rejection 5 5
Component or Accessory Incompatibility 4 4
Activation, Positioning or Separation Problem 4 4
Misassembly by Users 4 4
Appropriate Term/Code Not Available 4 4
Output Problem 3 3
Use of Device Problem 3 3
No Device Output 3 3
Leak/Splash 3 3
Loose or Intermittent Connection 2 2
Nonstandard Device 2 2
Material Separation 2 2
Improper or Incorrect Procedure or Method 2 2
Component Missing 2 2
Tear, Rip or Hole in Device Packaging 2 2
Patient-Device Incompatibility 2 2
Device Dislodged or Dislocated 2 2
Incomplete or Inadequate Connection 2 2
Activation Problem 2 2
Activation Failure 1 1
Device Fell 1 1
Migration 1 1
Ejection Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Protrusion/Extrusion 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Deformation Due to Compressive Stress 1 1
Separation Failure 1 1
Dull, Blunt 1 1
Structural Problem 1 1
Fitting Problem 1 1
Unexpected Therapeutic Results 1 1
Unraveled Material 1 1
Self-Activation or Keying 1 1
Unsealed Device Packaging 1 1
Off-Label Use 1 1
Fluid/Blood Leak 1 1
Fracture 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 441 441
Failure to Anastomose 170 170
Tissue Breakdown 169 169
Insufficient Information 95 95
Hemorrhage/Bleeding 44 44
No Known Impact Or Consequence To Patient 33 33
Wound Dehiscence 31 31
Laceration(s) 20 20
Unspecified Tissue Injury 20 20
Inflammation 13 13
Pain 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
No Consequences Or Impact To Patient 10 10
Unspecified Infection 7 7
Abscess 7 7
No Code Available 7 7
No Information 6 6
Hematoma 6 6
Post Operative Wound Infection 6 6
Unintended Radiation Exposure 5 5
Rectal Anastomotic Leakage 5 5
Ascites 4 4
Blood Loss 4 4
Bowel Perforation 4 4
Sepsis 4 4
Peritonitis 4 4
Fever 4 4
Perforation 4 4
Death 4 4
Emotional Changes 4 4
Abdominal Pain 3 3
Hypersensitivity/Allergic reaction 3 3
Distress 3 3
Scar Tissue 3 3
Tissue Damage 3 3
Foreign Body In Patient 3 3
Obstruction/Occlusion 3 3
Hernia 2 2
Injury 2 2
Fluid Discharge 2 2
Abdominal Distention 2 2
Organ Dehiscence 2 2
Urinary Retention 2 2
Urinary Tract Infection 2 2
Nausea 2 2
Tachycardia 2 2
Electrolyte Imbalance 2 2
Fistula 2 2
Foreign Body Reaction 2 2
Pneumothorax 2 2
Infiltration into Tissue 2 2
Adhesion(s) 2 2
Erythema 2 2
Purulent Discharge 2 2
Cellulitis 2 2
Unspecified Gastrointestinal Problem 2 2
Bronchial Hemorrhage 2 2
Swelling/ Edema 2 2
Intra-Abdominal Hemorrhage 1 1
Multiple Organ Failure 1 1
Vascular Dissection 1 1
Device Embedded In Tissue or Plaque 1 1
Fibrosis 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Decreased Appetite 1 1
Implant Pain 1 1
Chest Pain 1 1
Cyst(s) 1 1
Dyspnea 1 1
Exsanguination 1 1
Fatigue 1 1
Anemia 1 1
Aspiration/Inhalation 1 1
Cardiac Arrest 1 1
Abrasion 1 1
Ischemia 1 1
Renal Failure 1 1
Flatus 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Shock 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Muscle Weakness 1 1
Ventricular Fibrillation 1 1
Vomiting 1 1
Ambulation Difficulties 1 1
Deformity/ Disfigurement 1 1
Depression 1 1
Fungal Infection 1 1
Rupture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien, LP II Jul-01-2022
2 Intuitive Surgical, Inc. II May-05-2020
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