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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
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 96 96
2018 81 81
2019 70 70
2020 24 24
2021 33 33
2022 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Form Staple 53 53
Misfire 48 48
Failure to Fire 40 40
Break 28 28
Difficult to Open or Close 24 24
Mechanical Jam 20 20
Device Operates Differently Than Expected 18 18
Adverse Event Without Identified Device or Use Problem 17 17
Firing Problem 15 15
Difficult to Remove 12 12
Mechanical Problem 10 10
Insufficient Information 8 8
Noise, Audible 7 7
Detachment Of Device Component 7 7
Failure To Adhere Or Bond 6 6
Detachment of Device or Device Component 6 6
Device Dislodged or Dislocated 5 5
Fluid/Blood Leak 5 5
Failure to Cut 5 5
Defective Device 5 5
Appropriate Term/Code Not Available 5 5
Entrapment of Device 5 5
Loose or Intermittent Connection 5 5
Product Quality Problem 5 5
Device Appears to Trigger Rejection 5 5
Physical Resistance/Sticking 5 5
Positioning Failure 5 5
Activation, Positioning or Separation Problem 4 4
Nonstandard Device 3 3
Use of Device Problem 3 3
Material Twisted/Bent 3 3
Leak/Splash 3 3
Device Inoperable 2 2
Improper or Incorrect Procedure or Method 2 2
Fitting Problem 2 2
Patient-Device Incompatibility 2 2
Unsealed Device Packaging 2 2
Bent 2 2
Device Slipped 2 2
Output Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Misassembled 2 2
Self-Activation or Keying 2 2
Mechanics Altered 2 2
Difficult or Delayed Positioning 1 1
Device Damaged Prior to Use 1 1
Positioning Problem 1 1
Activation Failure 1 1
Delivered as Unsterile Product 1 1
Difficult to Insert 1 1
Failure to Disconnect 1 1
Malposition of Device 1 1
Connection Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Torn Material 1 1
Activation Problem 1 1
Deformation Due to Compressive Stress 1 1
Failure to Auto Stop 1 1
Other (for use when an appropriate device code cannot be identified) 1 1
Unknown (for use when the device problem is not known) 1 1
Component Missing 1 1
Failure to Calibrate 1 1
Structural Problem 1 1
Failure to Align 1 1
Retraction Problem 1 1
Crack 1 1
Degraded 1 1
Failure to Cycle 1 1
Fracture 1 1
Material Separation 1 1
Separation Failure 1 1
Physical Resistance 1 1
Off-Label Use 1 1
Air Leak 1 1
Gas/Air Leak 1 1
Material Protrusion/Extrusion 1 1
Patient Device Interaction Problem 1 1
Defective Component 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Advance 1 1
Device-Device Incompatibility 1 1
Device Contamination with Chemical or Other Material 1 1
Migration 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Partial Blockage 1 1
Contamination 1 1
Poor Quality Image 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 93 93
No Information 41 42
Failure to Anastomose 30 30
No Consequences Or Impact To Patient 29 29
Insufficient Information 20 20
No Clinical Signs, Symptoms or Conditions 17 17
No Code Available 17 17
Hemorrhage/Bleeding 16 16
Tissue Damage 14 14
Wound Dehiscence 12 12
Blood Loss 9 9
Death 9 9
Inflammation 8 8
Abdominal Pain 7 7
Patient Problem/Medical Problem 6 6
Post Operative Wound Infection 6 6
Sepsis 5 5
Abscess 4 4
Injury 4 4
No Patient Involvement 4 4
Unspecified Infection 4 4
Pain 4 4
Obstruction/Occlusion 4 4
Foreign Body In Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Complaint, Ill-Defined 3 3
Fever 3 3
Perforation 3 3
Rectal Anastomotic Leakage 2 2
Infiltration into Tissue 2 2
Tachycardia 2 2
Laceration(s) 2 2
Device Embedded In Tissue or Plaque 2 2
Bronchial Hemorrhage 2 2
Dyspnea 2 2
Exsanguination 2 2
Low Blood Pressure/ Hypotension 1 1
Aspiration/Inhalation 1 1
Cyst(s) 1 1
Organ Dehiscence 1 1
Atrial Perforation 1 1
Bowel Perforation 1 1
Intra-Abdominal Hemorrhage 1 1
Hypoxia 1 1
Nausea 1 1
Necrosis 1 1
Shock 1 1
Not Applicable 1 1
Implant Pain 1 1
Blister 1 1
Adhesion(s) 1 1
Cardiac Arrest 1 1
Purulent Discharge 1 1
Pneumothorax 1 1
Skin Irritation 1 1
Perforation of Vessels 1 1
Abdominal Distention 1 1
Vascular Dissection 1 1
Cancer 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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