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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 142 142

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 185 185
Overheating of Device 132 132
Temperature Problem 84 84
Circuit Failure 83 83
Smoking 63 63
Display or Visual Feedback Problem 62 62
Device Emits Odor 59 59
Electrical /Electronic Property Problem 52 52
No Display/Image 41 41
Failure to Power Up 32 32
Break 32 32
Adverse Event Without Identified Device or Use Problem 30 30
Melted 29 29
Poor Quality Image 27 27
Power Problem 22 22
Detachment of Device or Device Component 20 20
Intermittent Continuity 18 18
Intermittent Loss of Power 16 16
Use of Device Problem 15 15
Optical Problem 15 15
Thermal Decomposition of Device 13 13
Sparking 12 12
Mechanical Problem 12 12
Loss of Power 11 11
Unexpected Shutdown 10 10
Excessive Heating 9 9
Connection Problem 8 8
Noise, Audible 8 8
Computer Software Problem 8 8
Device Contaminated During Manufacture or Shipping 7 7
Electrical Shorting 7 7
No Device Output 6 6
Crack 6 6
Loose or Intermittent Connection 5 5
Failure to Shut Off 5 5
Environmental Compatibility Problem 4 4
Energy Output Problem 4 4
Environmental Particulates 4 4
Insufficient Information 4 4
Device Fell 4 4
Electrical Power Problem 4 4
Flare or Flash 4 4
Defective Device 3 3
Material Integrity Problem 3 3
Erratic or Intermittent Display 3 3
Appropriate Term/Code Not Available 3 3
Blocked Connection 3 3
Fire 3 3
Device Damaged Prior to Use 3 3
Application Program Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 593 593
No Known Impact Or Consequence To Patient 133 133
No Consequences Or Impact To Patient 83 83
Insufficient Information 68 68
Burn(s) 48 48
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
No Code Available 1 1
Abrasion 1 1
Shock 1 1
Unspecified Tissue Injury 1 1
Skin Burning Sensation 1 1

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