Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Form Staple 517 532
Mechanics Altered 290 290
Failure to Align 247 247
Failure to Fire 143 143
Mechanical Problem 96 96
Difficult to Open or Close 88 88
No Apparent Adverse Event 83 83
Break 83 83
Mechanical Jam 72 72
Detachment of Device or Device Component 67 67
Material Twisted/Bent 66 66
Activation, Positioning or Separation Problem 46 46
Appropriate Term/Code Not Available 31 31
Firing Problem 29 29
Adverse Event Without Identified Device or Use Problem 28 28
Insufficient Information 23 23
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
Loose or Intermittent Connection 11 11
Unintended Ejection 10 10
Material Separation 9 9
Defective Device 9 9
Physical Resistance/Sticking 9 9
Delivered as Unsterile Product 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
Material Deformation 5 5
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
Tear, Rip or Hole in Device Packaging 2 2
Output Problem 2 2
Material Fragmentation 2 2
Peeled/Delaminated 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
Device Difficult to Setup or Prepare 1 1
Material Puncture/Hole 1 1
Use of Device Problem 1 1
Retraction Problem 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
Packaging Problem 1 1
Material Protrusion/Extrusion 1 1
Malposition of Device 1 1
Device Misassembled During Manufacturing /Shipping 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 1036 1036
No Consequences Or Impact To Patient 407 422
Hemorrhage/Bleeding 90 90
Insufficient Information 45 45
No Known Impact Or Consequence To Patient 36 36
Unspecified Tissue Injury 19 19
No Information 9 9
Swelling/ Edema 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Perforation of Vessels 7 7
No Code Available 7 7
No Patient Involvement 5 5
Foreign Body In Patient 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
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1

-
-