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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

MDR Year MDR Reports MDR Events
2019 70 70
2020 47 47
2021 53 53
2022 48 48
2023 101 101
2024 262 262

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 116 116
Failure to Form Staple 100 100
Adverse Event Without Identified Device or Use Problem 70 70
Misfire 47 47
Detachment of Device or Device Component 37 37
Break 33 33
Difficult to Remove 26 26
Mechanics Altered 22 22
Mechanical Problem 18 18
Mechanical Jam 16 16
Firing Problem 15 15
Loss of or Failure to Bond 15 15
Failure to Align 15 15
Failure to Cut 12 12
Entrapment of Device 12 12
Insufficient Information 12 12
Human-Device Interface Problem 10 10
Material Twisted/Bent 8 8
Difficult to Open or Close 8 8
Therapeutic or Diagnostic Output Failure 8 8
Expulsion 7 7
Physical Resistance/Sticking 7 7
Defective Device 7 7
Device Slipped 6 6
Product Quality Problem 6 6
Device Appears to Trigger Rejection 5 5
Protective Measures Problem 5 5
Patient Device Interaction Problem 5 5
Noise, Audible 4 4
Activation, Positioning or Separation Problem 4 4
Appropriate Term/Code Not Available 4 4
Retraction Problem 4 4
Leak/Splash 3 3
Use of Device Problem 3 3
Output Problem 3 3
Fail-Safe Problem 2 2
Device Dislodged or Dislocated 2 2
Activation Problem 2 2
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
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
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
Activation Failure 1 1
Misassembly by Users 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 246 246
Failure to Anastomose 85 85
Insufficient Information 70 70
Tissue Breakdown 67 67
No Known Impact Or Consequence To Patient 33 33
Wound Dehiscence 29 29
Hemorrhage/Bleeding 27 27
Laceration(s) 12 12
No Consequences Or Impact To Patient 10 10
Unspecified Tissue Injury 10 10
Pain 9 9
Inflammation 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Code Available 7 7
No Information 6 6
Post Operative Wound Infection 6 6
Abscess 6 6
Unspecified Infection 5 5
Rectal Anastomotic Leakage 5 5
Blood Loss 4 4
Bowel Perforation 4 4
Hematoma 4 4
Death 4 4
Emotional Changes 4 4
Fever 3 3
Hypersensitivity/Allergic reaction 3 3
Abdominal Pain 3 3
Perforation 3 3
Tissue Damage 3 3
Ascites 3 3
Distress 3 3
Injury 2 2
Organ Dehiscence 2 2
Tachycardia 2 2
Obstruction/Occlusion 2 2
Fluid Discharge 2 2
Foreign Body In Patient 2 2
Bronchial Hemorrhage 2 2
Unintended Radiation Exposure 2 2
Urinary Retention 2 2
Urinary Tract Infection 2 2
Electrolyte Imbalance 2 2
Scar Tissue 2 2
Sepsis 2 2
Infiltration into Tissue 2 2
Purulent Discharge 2 2
Cellulitis 2 2
Fistula 2 2
Foreign Body Reaction 2 2
Erythema 2 2
Exsanguination 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Cyst(s) 1 1
Dyspnea 1 1
Adhesion(s) 1 1
Aspiration/Inhalation 1 1
Pneumothorax 1 1
Nausea 1 1
Shock 1 1
Hernia 1 1
Swelling/ Edema 1 1
Implant Pain 1 1
Intra-Abdominal Hemorrhage 1 1
Blister 1 1
Vascular Dissection 1 1
Device Embedded In Tissue or Plaque 1 1
Abdominal Distention 1 1
Deformity/ Disfigurement 1 1
Complaint, Ill-Defined 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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