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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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Misfire 53 53
Failure to Fire 49 49
Failure to Form Staple 48 48
Difficult to Open or Close 25 25
Mechanical Jam 25 25
Break 22 22
Device Operates Differently Than Expected 21 21
Difficult to Remove 20 20
Adverse Event Without Identified Device or Use Problem 20 20
Firing Problem 13 13
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
Device Dislodged or Dislocated 5 5
Defective Device 5 5
Appropriate Term/Code Not Available 5 5
Entrapment of Device 5 5
Loose or Intermittent Connection 4 4
Air Leak 4 4
Bent 3 3
Nonstandard Device 3 3
Use of Device Problem 3 3
Insufficient Information 3 3
Leak/Splash 3 3
Sticking 3 3
Device Inoperable 2 2
Self-Activation or Keying 2 2
Misassembled 2 2
Difficult to Insert 2 2
Physical Resistance/Sticking 2 2
Fitting Problem 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Failure to Advance 2 2
Device Slipped 2 2
Material Twisted/Bent 2 2
Output Problem 2 2
Unsealed Device Packaging 2 2
Patient-Device Incompatibility 2 2
Failure to Align 2 2
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
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
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

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 13 13
Injury 11 11
Death 9 9
Pain 7 7
Abdominal Pain 6 6
Patient Problem/Medical Problem 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
Insufficient Information 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Fever 4 4
Perforation 4 4
Inflammation 3 3
Abscess 3 3
Foreign Body In Patient 3 3
Device Embedded In Tissue or Plaque 2 2
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
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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