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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stapler, surgical
Regulation Description Manual surgical instrument for general use.
Product CodeGAG
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 74 74
2017 96 96
2018 81 81
2019 70 70
2020 24 24
2021 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Misfire 54 54
Failure to Form Staple 50 50
Failure to Fire 49 49
Mechanical Jam 26 26
Difficult to Open or Close 25 25
Break 24 24
Device Operates Differently Than Expected 21 21
Difficult to Remove 20 20
Adverse Event Without Identified Device or Use Problem 20 20
Firing Problem 14 14
Failure to Cut 11 11
Mechanical Problem 11 11
Failure To Adhere Or Bond 10 10
Detachment Of Device Component 9 9
Noise, Audible 9 9
Fluid Leak 7 7
Positioning Failure 6 6
Activation, Positioning or SeparationProblem 6 6
Detachment of Device or Device Component 6 6
Entrapment of Device 6 6
Device Dislodged or Dislocated 5 5
Defective Device 5 5
Appropriate Term/Code Not Available 5 5
Air Leak 4 4
Loose or Intermittent Connection 4 4
Leak/Splash 3 3
Sticking 3 3
Physical Resistance/Sticking 3 3
Bent 3 3
Nonstandard Device 3 3
Use of Device Problem 3 3
Insufficient Information 3 3
Material Twisted/Bent 3 3
Device Slipped 2 2
Output Problem 2 2
Unsealed Device Packaging 2 2
Patient-Device Incompatibility 2 2
Failure to Align 2 2
Fitting Problem 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Device Inoperable 2 2
Self-Activation or Keying 2 2
Misassembled 2 2
Difficult to Insert 2 2
Failure to Advance 2 2
Partial Blockage 1 1
Component Falling 1 1
Contamination 1 1
Difficult or Delayed Positioning 1 1
Poor Quality Image 1 1
Delivered as Unsterile Product 1 1
Product Quality Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Tear, Rip or Hole in Device Packaging 1 1
Malposition of Device 1 1
Connection Problem 1 1
Device-Device Incompatibility 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanics Altered 1 1
Device Fell 1 1
Failure to Disconnect 1 1
Positioning Problem 1 1
Activation Failure 1 1
Migration 1 1
Separation Failure 1 1
Physical Resistance 1 1
Retraction Problem 1 1
Material Separation 1 1
Deformation Due to Compressive Stress 1 1
Failure to Auto Stop 1 1
Gas Leak 1 1
Material Protrusion/Extrusion 1 1
Device Packaging Compromised 1 1
Off-Label Use 1 1
Migration or Expulsion of Device 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
Out-Of-Box Failure 1 1
Failure to Calibrate 1 1
Structural Problem 1 1
Crack 1 1
Failure to Cycle 1 1
Degraded 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Patient Device Interaction Problem 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 109 109
No Information 45 46
No Code Available 35 35
No Consequences Or Impact To Patient 34 34
Tissue Damage 28 28
Failure to Anastomose 26 26
Blood Loss 16 16
Hemorrhage/Bleeding 14 14
Injury 11 11
Death 9 9
No Clinical Signs, Symptoms or Conditions 8 8
Pain 7 7
Abdominal Pain 6 6
Patient Problem/Medical Problem 6 6
Insufficient Information 6 6
Wound Dehiscence 6 6
Sepsis 5 5
No Patient Involvement 5 5
Unspecified Infection 5 5
Obstruction/Occlusion 5 5
Complaint, Ill-Defined 4 4
Fever 4 4
Inflammation 4 4
Perforation 4 4
Abscess 3 3
Foreign Body In Patient 3 3
Device Embedded In Tissue or Plaque 3 3
Tachycardia 2 2
Dyspnea 2 2
Exsanguination 2 2
Infiltration into Tissue 2 2
Rectal Anastomotic Leakage 2 2
Skin Irritation 1 1
Perforation of Vessels 1 1
Vascular Dissection 1 1
Cancer 1 1
Muscle Spasm(s) 1 1
Organ Dehiscence 1 1
Atrial Perforation 1 1
Skin Tears 1 1
Abdominal Distention 1 1
Hematoma 1 1
Low Blood Pressure/ Hypotension 1 1
Aspiration/Inhalation 1 1
Cyst(s) 1 1
Implant Pain 1 1
Not Applicable 1 1
Pneumothorax 1 1
Shock 1 1
Hypoxia 1 1
Laceration(s) 1 1
Nausea 1 1
Necrosis 1 1
Nerve Damage 1 1
Internal Organ Perforation 1 1
Adhesion(s) 1 1
Cardiac Arrest 1 1
Purulent Discharge 1 1
Fistula 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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