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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 22 22
2022 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Misfire 43 43
Failure to Form Staple 42 42
Failure to Fire 38 38
Difficult to Open or Close 24 24
Break 24 24
Mechanical Jam 20 20
Device Operates Differently Than Expected 18 18
Firing Problem 14 14
Adverse Event Without Identified Device or Use Problem 13 13
Difficult to Remove 12 12
Mechanical Problem 10 10
Detachment Of Device Component 7 7
Noise, Audible 7 7
Failure To Adhere Or Bond 6 6
Detachment of Device or Device Component 6 6
Appropriate Term/Code Not Available 5 5
Device Dislodged or Dislocated 5 5
Loose or Intermittent Connection 5 5
Failure to Cut 5 5
Defective Device 5 5
Positioning Failure 5 5
Entrapment of Device 5 5
Fluid Leak 5 5
Activation, Positioning or SeparationProblem 4 4
Physical Resistance/Sticking 4 4
Material Twisted/Bent 3 3
Leak/Splash 3 3
Nonstandard Device 3 3
Insufficient Information 3 3
Misassembled 2 2
Bent 2 2
Unsealed Device Packaging 2 2
Self-Activation or Keying 2 2
Device Slipped 2 2
Device Inoperable 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Fitting Problem 2 2
Output Problem 2 2
Patient-Device Incompatibility 2 2
Deformation Due to Compressive Stress 1 1
Connection Problem 1 1
Failure to Auto Stop 1 1
Device Contamination with Chemical or Other Material 1 1
Gas Leak 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Protrusion/Extrusion 1 1
Malposition of Device 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Physical Resistance 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Device-Device Incompatibility 1 1
Device Fell 1 1
Activation Problem 1 1
Activation Failure 1 1
Mechanics Altered 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
Device Damaged Prior to Use 1 1
Defective Component 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Calibrate 1 1
Structural Problem 1 1
Failure to Align 1 1
Failure to Advance 1 1
Sticking 1 1
Material Separation 1 1
Off-Label Use 1 1
Retraction Problem 1 1
Partial Blockage 1 1
Air Leak 1 1
Poor Quality Image 1 1
Delivered as Unsterile Product 1 1
Difficult to Insert 1 1
Contamination 1 1
Crack 1 1
Failure to Cycle 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1
Patient Device Interaction Problem 1 1
Migration 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
No Consequences Or Impact To Patient 29 29
Failure to Anastomose 22 22
No Code Available 17 17
Hemorrhage/Bleeding 14 14
Tissue Damage 13 13
No Clinical Signs, Symptoms or Conditions 13 13
Insufficient Information 10 10
Blood Loss 9 9
Death 9 9
Wound Dehiscence 6 6
Abdominal Pain 6 6
Patient Problem/Medical Problem 6 6
Sepsis 5 5
Pain 4 4
Inflammation 4 4
Injury 4 4
Obstruction/Occlusion 4 4
Unspecified Infection 4 4
No Patient Involvement 4 4
Foreign Body In Patient 3 3
Complaint, Ill-Defined 3 3
Abscess 3 3
Fever 3 3
Perforation 3 3
Tachycardia 2 2
Infiltration into Tissue 2 2
Dyspnea 2 2
Exsanguination 2 2
Bronchial Hemorrhage 2 2
Device Embedded In Tissue or Plaque 2 2
Rectal Anastomotic Leakage 2 2
Implant Pain 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Not Applicable 1 1
Vascular Dissection 1 1
Intra-Abdominal Hemorrhage 1 1
Cancer 1 1
Abdominal Distention 1 1
Bowel Perforation 1 1
Purulent Discharge 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Adhesion(s) 1 1
Aspiration/Inhalation 1 1
Cardiac Arrest 1 1
Cyst(s) 1 1
Perforation of Vessels 1 1
Organ Dehiscence 1 1
Atrial Perforation 1 1
Pneumothorax 1 1
Shock 1 1
Skin Irritation 1 1
Laceration(s) 1 1
Nausea 1 1
Necrosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 COVIDIEN LLC II Oct-04-2018
2 Intuitive Surgical, Inc. II May-05-2020
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