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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laryngoscope, endoscope
Regulation Description Endoscope and accessories.
Product CodeGCI
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2020 129 129
2021 96 96
2022 102 102
2023 101 101
2024 119 119
2025 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 412 412
Detachment of Device or Device Component 108 108
Material Separation 51 51
Break 45 45
Adverse Event Without Identified Device or Use Problem 13 13
Difficult to Remove 4 4
Display or Visual Feedback Problem 4 4
Insufficient Information 4 4
Mechanics Altered 3 3
Defective Device 3 3
Entrapment of Device 3 3
Difficult to Insert 3 3
No Apparent Adverse Event 2 2
Device Difficult to Maintain 2 2
Tear, Rip or Hole in Device Packaging 1 1
Activation Problem 1 1
Material Protrusion/Extrusion 1 1
Material Rupture 1 1
Optical Problem 1 1
Difficult to Open or Close 1 1
Patient Device Interaction Problem 1 1
Device Dislodged or Dislocated 1 1
Physical Resistance/Sticking 1 1
Failure to Align 1 1
Unexpected Therapeutic Results 1 1
No Display/Image 1 1
Smoking 1 1
Retraction Problem 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 344 344
No Consequences Or Impact To Patient 80 80
Insufficient Information 78 78
No Information 26 26
Unspecified Tissue Injury 20 20
Foreign Body In Patient 17 17
No Code Available 12 12
Laceration(s) 7 7
Unintended Radiation Exposure 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Patient Involvement 3 3
Vascular Dissection 3 3
Death 2 2
Unspecified Infection 2 2
Tissue Breakdown 2 2
Device Embedded In Tissue or Plaque 2 2
Exposure to Body Fluids 1 1
Purulent Discharge 1 1
Exsanguination 1 1
Hemorrhage/Bleeding 1 1
Injury 1 1
Post Traumatic Wound Infection 1 1
Tissue Damage 1 1
Rupture 1 1
No Known Impact Or Consequence To Patient 1 1

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