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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laryngoscope, endoscope
Product CodeGCI
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2019 135 135
2020 129 129
2021 96 96
2022 102 102
2023 101 101
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 439 439
Detachment of Device or Device Component 126 126
Break 50 50
Material Separation 46 46
Adverse Event Without Identified Device or Use Problem 14 14
Difficult to Remove 7 7
Display or Visual Feedback Problem 4 4
Difficult to Insert 4 4
Entrapment of Device 3 3
Defective Device 3 3
Mechanics Altered 2 2
Insufficient Information 2 2
Patient Device Interaction Problem 1 1
Optical Problem 1 1
Device Difficult to Maintain 1 1
Retraction Problem 1 1
Material Rupture 1 1
Physical Resistance/Sticking 1 1
Activation Problem 1 1
No Display/Image 1 1
Leak/Splash 1 1
Mechanical Problem 1 1
Poor Quality Image 1 1
Material Puncture/Hole 1 1
Smoking 1 1
Unexpected Therapeutic Results 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Align 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 263 263
No Consequences Or Impact To Patient 171 171
Insufficient Information 57 57
No Information 36 36
No Known Impact Or Consequence To Patient 25 25
No Code Available 23 23
Unspecified Tissue Injury 20 20
Foreign Body In Patient 19 19
No Patient Involvement 7 7
Unintended Radiation Exposure 5 5
Vascular Dissection 3 3
Death 2 2
Laceration(s) 2 2
Pain 2 2
Tissue Damage 2 2
Device Embedded In Tissue or Plaque 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Vomiting 1 1
Septic Shock 1 1
Nausea 1 1
Exsanguination 1 1
Unspecified Infection 1 1
Radiation Exposure, Unintended 1 1
Tissue Breakdown 1 1
Rupture 1 1
Injury 1 1
Post Traumatic Wound Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien Llc II Jun-03-2020
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