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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 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 163 163
Overheating of Device 118 118
Temperature Problem 66 66
Circuit Failure 66 66
Smoking 55 55
Device Emits Odor 53 53
Electrical /Electronic Property Problem 51 51
Display or Visual Feedback Problem 49 49
No Display/Image 40 40
Adverse Event Without Identified Device or Use Problem 30 30
Break 29 29
Failure to Power Up 28 28
Melted 27 27
Poor Quality Image 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 14 14
Thermal Decomposition of Device 13 13
Sparking 12 12
Loss of Power 11 11
Mechanical Problem 11 11
Use of Device Problem 11 11
Unexpected Shutdown 9 9
Excessive Heating 7 7
Connection Problem 7 7
No Device Output 6 6
Computer Software Problem 6 6
Crack 5 5
Loose or Intermittent Connection 5 5
Failure to Shut Off 5 5
Electrical Shorting 5 5
Noise, Audible 5 5
Insufficient Information 4 4
Device Fell 4 4
Environmental Compatibility Problem 4 4
Environmental Particulates 4 4
Electrical Power Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Flare or Flash 4 4
Energy Output Problem 4 4
Erratic or Intermittent Display 3 3
Fire 3 3
Defective Device 3 3
Application Program Problem 3 3
Blocked Connection 3 3
Appropriate Term/Code Not Available 3 3
Device Handling Problem 2 2
Complete Loss of Power 2 2
Intermittent Energy Output 2 2
Separation Problem 2 2
Human-Device Interface Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Material Integrity Problem 2 2
Activation, Positioning or Separation Problem 2 2
Disconnection 2 2
Unintended Power Up 2 2
Output above Specifications 2 2
Improper or Incorrect Procedure or Method 2 2
Electro-Static Discharge 1 1
Fitting Problem 1 1
Defective Component 1 1
Failure to Align 1 1
Fumes or Vapors 1 1
Arcing 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
Mechanics Altered 1 1
Reset Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Optical Obstruction 1 1
Component or Accessory Incompatibility 1 1
Loss of Data 1 1
Device-Device Incompatibility 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Power Conditioning Problem 1 1
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 497 497
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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