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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device applier, surgical, clip
Product CodeGDO
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2017 315 315
2018 368 368
2019 293 308
2020 221 221
2021 304 304
2022 361 361

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Form Staple 505 520
Failure to Align 268 268
Mechanics Altered 225 225
Difficult to Open or Close 171 171
Break 144 144
Failure to Fire 112 112
Mechanical Problem 87 87
Activation, Positioning or Separation Problem 85 85
Detachment of Device or Device Component 76 76
Mechanical Jam 62 62
Material Twisted/Bent 60 60
Device Operates Differently Than Expected 49 49
No Apparent Adverse Event 48 48
Misfire 32 32
Firing Problem 27 27
Appropriate Term/Code Not Available 25 25
Loose or Intermittent Connection 25 25
Adverse Event Without Identified Device or Use Problem 24 24
Detachment Of Device Component 23 23
Entrapment of Device 21 21
Premature Activation 19 19
Leak/Splash 19 19
Bent 17 17
Insufficient Information 17 17
Separation Failure 16 16
Difficult to Remove 16 16
Device Fell 15 15
Material Integrity Problem 14 14
Defective Device 14 14
Unintended Ejection 13 13
Device Slipped 12 12
Material Deformation 11 11
Positioning Failure 9 9
Difficult To Position 8 8
Material Separation 8 8
Physical Resistance/Sticking 8 8
Noise, Audible 7 7
Peeled/Delaminated 7 7
Component Falling 7 7
Delivered as Unsterile Product 6 6
Fail-Safe Problem 6 6
Positioning Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Therapeutic or Diagnostic Output Failure 5 5
Separation Problem 5 5
Difficult to Open or Remove Packaging Material 5 5
Device Dislodged or Dislocated 4 4
Device Inoperable 4 4
Failure to Advance 4 4
Defective Component 4 4
Material Fragmentation 4 4
Corroded 4 4
Crack 4 4
Activation Problem 4 4
Material Split, Cut or Torn 3 3
Output Problem 3 3
Naturally Worn 3 3
Difficult to Fold, Unfold or Collapse 3 3
Improper or Incorrect Procedure or Method 3 3
Failure to Deliver 2 2
Tear, Rip or Hole in Device Packaging 2 2
Physical Resistance 2 2
Malposition of Device 2 2
Patient-Device Incompatibility 2 2
Fracture 2 2
Difficult or Delayed Positioning 2 2
Difficult to Insert 2 2
Failure To Adhere Or Bond 2 2
Flaked 2 2
Unintended Movement 2 2
Device Contamination with Chemical or Other Material 2 2
Incorrect Device Or Component Shipped 2 2
Activation Failure 2 2
Failure to Eject 2 2
Migration 1 1
Device Handling Problem 1 1
Ejection Problem 1 1
Difficult or Delayed Separation 1 1
Premature Separation 1 1
Inadequate User Interface 1 1
Material Distortion 1 1
Material Protrusion/Extrusion 1 1
Packaging Problem 1 1
Fluid/Blood Leak 1 1
Disconnection 1 1
Material Disintegration 1 1
Display or Visual Feedback Problem 1 1
Complete Blockage 1 1
Collapse 1 1
Degraded 1 1
Contamination 1 1
Inadequate Instructions for Healthcare Professional 1 1
Hole In Material 1 1
Nonstandard Device 1 1
Device Difficult to Setup or Prepare 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Application Program Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Failure to Cut 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 953 968
No Clinical Signs, Symptoms or Conditions 654 654
No Known Impact Or Consequence To Patient 126 126
Hemorrhage/Bleeding 42 42
Insufficient Information 27 27
No Code Available 18 18
No Information 17 17
Tissue Damage 17 17
Blood Loss 13 13
No Patient Involvement 11 11
Unspecified Tissue Injury 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Swelling/ Edema 8 8
Foreign Body In Patient 7 7
Perforation of Vessels 7 7
Hematoma 6 6
Not Applicable 6 6
Cardiac Arrest 5 5
Laceration(s) 4 4
Dyspnea 3 3
Device Embedded In Tissue or Plaque 3 3
Fever 2 2
Failure to Anastomose 2 2
Abdominal Pain 2 2
Nerve Damage 2 2
Pain 1 1
Pleural Effusion 1 1
Renal Failure 1 1
Swelling 1 1
Hemostasis 1 1
Inflammation 1 1
Abscess 1 1
Adult Respiratory Distress Syndrome 1 1
Wound Dehiscence 1 1
Exsanguination 1 1
Patient Problem/Medical Problem 1 1
Abdominal Distention 1 1
Injury 1 1
Post Operative Wound Infection 1 1
Unintended Radiation Exposure 1 1

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