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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
2019 293 308
2020 221 221
2021 304 304
2022 361 361
2023 368 368
2024 130 130

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Form Staple 538 553
Mechanics Altered 296 296
Failure to Align 269 269
Failure to Fire 146 146
Mechanical Problem 100 100
Difficult to Open or Close 95 95
Break 89 89
No Apparent Adverse Event 87 87
Mechanical Jam 76 76
Material Twisted/Bent 69 69
Detachment of Device or Device Component 68 68
Activation, Positioning or Separation Problem 46 46
Appropriate Term/Code Not Available 31 31
Adverse Event Without Identified Device or Use Problem 29 29
Firing Problem 29 29
Insufficient Information 27 27
Entrapment of Device 18 18
Material Integrity Problem 16 16
Device Fell 15 15
Leak/Splash 15 15
Misfire 14 14
Difficult to Remove 12 12
Unintended Ejection 12 12
Loose or Intermittent Connection 11 11
Material Separation 9 9
Defective Device 9 9
Physical Resistance/Sticking 9 9
Delivered as Unsterile Product 8 8
Material Deformation 8 8
Fail-Safe Problem 8 8
Noise, Audible 7 7
Device Slipped 7 7
Patient Device Interaction Problem 6 6
Activation Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Difficult to Open or Remove Packaging Material 5 5
Separation Problem 5 5
Positioning Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Separation Failure 5 5
Fracture 5 5
Corroded 4 4
Improper or Incorrect Procedure or Method 4 4
Difficult to Insert 3 3
Product Quality Problem 3 3
Difficult to Fold, Unfold or Collapse 3 3
Device Handling Problem 3 3
Activation Failure 2 2
Unintended Movement 2 2
Difficult or Delayed Separation 2 2
Device Dislodged or Dislocated 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Tear, Rip or Hole in Device Packaging 2 2
Output Problem 2 2
Packaging Problem 2 2
Material Fragmentation 2 2
Peeled/Delaminated 2 2
Use of Device Problem 2 2
Failure to Advance 2 2
Dent in Material 1 1
Defective Component 1 1
Failure to Deliver 1 1
Difficult or Delayed Activation 1 1
Retraction Problem 1 1
Device Difficult to Setup or Prepare 1 1
Material Puncture/Hole 1 1
Unsealed Device Packaging 1 1
Nonstandard Device 1 1
Collapse 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1
Disconnection 1 1
Material Disintegration 1 1
Display or Visual Feedback Problem 1 1
Material Protrusion/Extrusion 1 1
Malposition of Device 1 1
Migration 1 1
Ejection Problem 1 1
Failure to Eject 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1099 1099
No Consequences Or Impact To Patient 407 422
Hemorrhage/Bleeding 95 95
Insufficient Information 46 46
No Known Impact Or Consequence To Patient 36 36
Unspecified Tissue Injury 21 21
No Information 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Swelling/ Edema 8 8
Perforation of Vessels 7 7
No Code Available 7 7
Foreign Body In Patient 7 7
No Patient Involvement 5 5
Inflammation 5 5
Pain 5 5
Tissue Damage 5 5
Hematoma 4 4
Cardiac Arrest 4 4
Dyspnea 3 3
Blood Loss 3 3
Unintended Radiation Exposure 2 2
Failure to Anastomose 2 2
Laceration(s) 2 2
Nerve Damage 2 2
Hemostasis 1 1
Unspecified Infection 1 1
Pleural Effusion 1 1
Renal Failure 1 1
Wound Dehiscence 1 1
Abdominal Pain 1 1
Abscess 1 1
Adult Respiratory Distress Syndrome 1 1
Exsanguination 1 1
Fever 1 1
Tissue Breakdown 1 1
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1

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