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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 1
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 108 108
2024 381 381

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 149 149
Failure to Form Staple 120 120
Adverse Event Without Identified Device or Use Problem 86 86
Detachment of Device or Device Component 61 61
Misfire 58 58
Break 43 43
Mechanics Altered 37 37
Difficult to Remove 31 31
Loss of or Failure to Bond 23 23
Mechanical Problem 18 18
Failure to Align 17 17
Mechanical Jam 16 16
Firing Problem 15 15
Human-Device Interface Problem 14 14
Insufficient Information 13 13
Failure to Cut 13 13
Entrapment of Device 13 13
Material Twisted/Bent 11 11
Expulsion 10 10
Difficult to Open or Close 10 10
Noise, Audible 10 10
Physical Resistance/Sticking 8 8
Therapeutic or Diagnostic Output Failure 8 8
Defective Device 7 7
Device Slipped 7 7
Product Quality Problem 6 6
Protective Measures Problem 6 6
Patient Device Interaction Problem 5 5
Device Appears to Trigger Rejection 5 5
Retraction Problem 4 4
Appropriate Term/Code Not Available 4 4
Activation, Positioning or Separation Problem 4 4
Fail-Safe Problem 4 4
Misassembly by Users 3 3
Output Problem 3 3
Leak/Splash 3 3
Use of Device Problem 3 3
Component Missing 2 2
Tear, Rip or Hole in Device Packaging 2 2
Patient-Device Incompatibility 2 2
Loose or Intermittent Connection 2 2
Nonstandard Device 2 2
No Device Output 2 2
Component or Accessory Incompatibility 2 2
Device Dislodged or Dislocated 2 2
Activation Problem 2 2
Activation Failure 1 1
Migration 1 1
Ejection Problem 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Device Contamination with Chemical or Other Material 1 1
Material Protrusion/Extrusion 1 1
Positioning Problem 1 1
Unsealed Device Packaging 1 1
Off-Label Use 1 1
Fluid/Blood Leak 1 1
Fracture 1 1
Self-Activation or Keying 1 1
Material Separation 1 1
Deformation Due to Compressive Stress 1 1
Separation Failure 1 1
Dull, Blunt 1 1
Structural Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Unexpected Therapeutic Results 1 1
Unraveled Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 319 319
Failure to Anastomose 114 114
Tissue Breakdown 108 108
Insufficient Information 75 75
Hemorrhage/Bleeding 37 37
No Known Impact Or Consequence To Patient 33 33
Wound Dehiscence 30 30
Laceration(s) 16 16
Unspecified Tissue Injury 14 14
Inflammation 11 11
Pain 10 10
No Consequences Or Impact To Patient 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
No Code Available 7 7
Unspecified Infection 7 7
Abscess 7 7
Hematoma 6 6
Post Operative Wound Infection 6 6
No Information 6 6
Rectal Anastomotic Leakage 5 5
Bowel Perforation 4 4
Unintended Radiation Exposure 4 4
Ascites 4 4
Blood Loss 4 4
Death 4 4
Emotional Changes 4 4
Abdominal Pain 3 3
Fever 3 3
Hypersensitivity/Allergic reaction 3 3
Perforation 3 3
Obstruction/Occlusion 3 3
Peritonitis 3 3
Distress 3 3
Scar Tissue 3 3
Tissue Damage 3 3
Urinary Retention 2 2
Urinary Tract Infection 2 2
Sepsis 2 2
Hernia 2 2
Nausea 2 2
Tachycardia 2 2
Electrolyte Imbalance 2 2
Organ Dehiscence 2 2
Injury 2 2
Abdominal Distention 2 2
Fluid Discharge 2 2
Foreign Body In Patient 2 2
Infiltration into Tissue 2 2
Fistula 2 2
Foreign Body Reaction 2 2
Adhesion(s) 2 2
Erythema 2 2
Purulent Discharge 2 2
Cellulitis 2 2
Swelling/ Edema 2 2
Bronchial Hemorrhage 2 2
Intra-Abdominal Hemorrhage 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Implant Pain 1 1
Decreased Appetite 1 1
Cyst(s) 1 1
Dyspnea 1 1
Exsanguination 1 1
Fatigue 1 1
Anemia 1 1
Aspiration/Inhalation 1 1
Abrasion 1 1
Flatus 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Ischemia 1 1
Pneumothorax 1 1
Renal Failure 1 1
Vascular Dissection 1 1
Device Embedded In Tissue or Plaque 1 1
Fibrosis 1 1
Deformity/ Disfigurement 1 1
Depression 1 1
Fungal Infection 1 1
Ambulation Difficulties 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Shock 1 1
Muscle Weakness 1 1
Vomiting 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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