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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light source, fiberoptic, routine
Product CodeFCW
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2019 118 118
2020 152 152
2021 147 147
2022 166 166
2023 179 179
2024 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 165 165
Overheating of Device 118 118
Circuit Failure 72 72
Temperature Problem 66 66
Smoking 56 56
Device Emits Odor 54 54
Display or Visual Feedback Problem 52 52
Electrical /Electronic Property Problem 51 51
No Display/Image 41 41
Adverse Event Without Identified Device or Use Problem 30 30
Failure to Power Up 30 30
Break 29 29
Poor Quality Image 27 27
Melted 27 27
Power Problem 20 20
Intermittent Continuity 18 18
Detachment of Device or Device Component 16 16
Optical Problem 15 15
Intermittent Loss of Power 15 15
Thermal Decomposition of Device 13 13
Sparking 12 12
Use of Device Problem 11 11
Mechanical Problem 11 11
Loss of Power 11 11
Unexpected Shutdown 9 9
Device Contaminated During Manufacture or Shipping 7 7
Excessive Heating 7 7
Connection Problem 7 7
No Device Output 6 6
Computer Software Problem 6 6
Loose or Intermittent Connection 5 5
Failure to Shut Off 5 5
Crack 5 5
Noise, Audible 5 5
Electrical Shorting 5 5
Environmental Compatibility Problem 4 4
Environmental Particulates 4 4
Insufficient Information 4 4
Electrical Power Problem 4 4
Device Fell 4 4
Flare or Flash 4 4
Energy Output Problem 4 4
Fire 3 3
Appropriate Term/Code Not Available 3 3
Defective Device 3 3
Blocked Connection 3 3
Erratic or Intermittent Display 3 3
Device Damaged Prior to Use 3 3
Application Program Problem 3 3
Device Handling Problem 2 2
Unintended Movement 2 2
Complete Loss of Power 2 2
Disconnection 2 2
Separation Problem 2 2
Activation, Positioning or Separation Problem 2 2
Intermittent Energy Output 2 2
Therapeutic or Diagnostic Output Failure 2 2
Output above Specifications 2 2
Unintended Power Up 2 2
Human-Device Interface Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Material Integrity Problem 2 2
Loss of Data 1 1
Defective Component 1 1
Material Discolored 1 1
Electro-Static Discharge 1 1
Power Conditioning Problem 1 1
Illegible Information 1 1
Material Frayed 1 1
Explosion 1 1
Optical Obstruction 1 1
Intermittent Communication Failure 1 1
Material Puncture/Hole 1 1
No Audible Alarm 1 1
Failure to Align 1 1
Premature Separation 1 1
Mechanics Altered 1 1
Device Alarm System 1 1
Device Contamination with Chemical or Other Material 1 1
Arcing 1 1
Reset Problem 1 1
Fitting Problem 1 1
Physical Resistance/Sticking 1 1
Image Display Error/Artifact 1 1
Device-Device Incompatibility 1 1
Positioning Failure 1 1
Material Separation 1 1
Fumes or Vapors 1 1
Component Incompatible 1 1
Component or Accessory Incompatibility 1 1
Mechanical Jam 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 511 511
No Known Impact Or Consequence To Patient 133 133
No Consequences Or Impact To Patient 83 83
Insufficient Information 67 67
Burn(s) 44 44
No Patient Involvement 16 16
Superficial (First Degree) Burn 14 14
Not Applicable 11 11
Burn, Thermal 9 9
Patient Problem/Medical Problem 2 2
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 2 2
Electric Shock 1 1
Shock 1 1
No Code Available 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Corporation II Apr-28-2023
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