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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 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 171 171
Overheating of Device 122 122
Circuit Failure 76 76
Temperature Problem 67 67
Smoking 60 60
Device Emits Odor 55 55
Display or Visual Feedback Problem 54 54
Electrical /Electronic Property Problem 52 52
No Display/Image 41 41
Failure to Power Up 32 32
Adverse Event Without Identified Device or Use Problem 30 30
Break 30 30
Melted 29 29
Poor Quality Image 27 27
Power Problem 21 21
Detachment of Device or Device Component 18 18
Intermittent Continuity 18 18
Intermittent Loss of Power 16 16
Optical Problem 15 15
Thermal Decomposition of Device 13 13
Use of Device Problem 13 13
Sparking 12 12
Loss of Power 11 11
Mechanical Problem 11 11
Unexpected Shutdown 9 9
Excessive Heating 8 8
Connection Problem 8 8
Device Contaminated During Manufacture or Shipping 7 7
Electrical Shorting 6 6
No Device Output 6 6
Crack 6 6
Computer Software Problem 6 6
Noise, Audible 6 6
Loose or Intermittent Connection 5 5
Failure to Shut Off 5 5
Flare or Flash 4 4
Environmental Compatibility Problem 4 4
Environmental Particulates 4 4
Electrical Power Problem 4 4
Insufficient Information 4 4
Energy Output Problem 4 4
Device Fell 4 4
Erratic or Intermittent Display 3 3
Fire 3 3
Appropriate Term/Code Not Available 3 3
Defective Device 3 3
Application Program Problem 3 3
Blocked Connection 3 3
Device Damaged Prior to Use 3 3
Activation, Positioning or Separation Problem 2 2
Device Handling Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Human-Device Interface Problem 2 2
Material Integrity Problem 2 2
Disconnection 2 2
Unintended Power Up 2 2
Output above Specifications 2 2
Improper or Incorrect Procedure or Method 2 2
Complete Loss of Power 2 2
Intermittent Energy Output 2 2
Separation Problem 2 2
Mechanics Altered 2 2
Premature Separation 1 1
Illegible Information 1 1
Intermittent Communication Failure 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Physical Resistance/Sticking 1 1
Electro-Static Discharge 1 1
Fitting Problem 1 1
Power Conditioning Problem 1 1
Material Discolored 1 1
Material Frayed 1 1
Image Display Error/Artifact 1 1
Positioning Failure 1 1
Component Incompatible 1 1
Device Alarm System 1 1
No Audible Alarm 1 1
Mechanical Jam 1 1
Device Contamination with Chemical or Other Material 1 1
Optical Obstruction 1 1
Reset Problem 1 1
Device Sensing Problem 1 1
Device-Device Incompatibility 1 1
Loss of Data 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Defective Component 1 1
Failure to Align 1 1
Fumes or Vapors 1 1
Arcing 1 1
Component or Accessory Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 536 536
No Known Impact Or Consequence To Patient 133 133
No Consequences Or Impact To Patient 83 83
Insufficient Information 68 68
Burn(s) 47 47
No Patient Involvement 16 16
Superficial (First Degree) Burn 15 15
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
Abrasion 1 1

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