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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
2016 100 149
2017 130 130
2018 102 102
2019 135 135
2020 129 129
2021 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 272 272
Torn Material 151 167
Detachment of Device or Device Component 98 98
Break 86 89
Detachment Of Device Component 58 64
Material Separation 57 65
Material Rupture 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Difficult to Remove 7 7
Difficult to Open or Close 4 4
Difficult to Insert 4 4
Material Fragmentation 3 3
Bent 3 3
Failure to Charge 2 2
Difficult or Delayed Positioning 2 2
Hole In Material 2 2
Material Puncture/Hole 2 2
Positioning Problem 2 2
Mechanics Altered 2 2
Device Difficult to Maintain 2 2
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Device Packaging Compromised 1 1
Optical Problem 1 1
Physical Resistance/Sticking 1 1
Activation Problem 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Device Dislodged or Dislocated 1 1
Environmental Particulates 1 1
Device Contamination with Chemical or Other Material 1 1
Smoking 1 1
Device Inoperable 1 17
Use of Device Problem 1 1
Material Perforation 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Defective Device 1 1
Activation, Positioning or SeparationProblem 1 1
Component Falling 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Poor Quality Image 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Entrapment of Device 1 1
Burst Container or Vessel 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 251 273
No Consequences Or Impact To Patient 243 243
No Clinical Signs, Symptoms or Conditions 75 75
No Information 47 70
No Code Available 40 44
Insufficient Information 16 16
Foreign Body In Patient 15 15
No Patient Involvement 12 12
Tissue Damage 5 5
Device Embedded In Tissue or Plaque 5 5
Radiation Exposure, Unintended 4 4
Pain 2 2
Death 2 2
Unspecified Tissue Injury 2 2
Unintended Radiation Exposure 1 1
Exsanguination 1 1
Unspecified Infection 1 1
Nausea 1 1
Septic Shock 1 1
Vomiting 1 1
Vascular Dissection 1 1
Abscess 1 1
Injury 1 1
Blood Loss 1 1

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