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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
Regulation Description Endoscope and accessories.
Product CodeFCW
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2021 147 147
2022 166 166
2023 179 179
2024 178 178
2025 141 141
2026 94 94

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 168 168
Overheating of Device 165 165
Display or Visual Feedback Problem 131 131
Circuit Failure 87 87
Smoking 85 85
Temperature Problem 60 60
Device Emits Odor 39 39
Break 37 37
Detachment of Device or Device Component 35 35
Use of Device Problem 33 33
Failure to Power Up 33 33
Connection Problem 25 25
Optical Problem 19 19
Adverse Event Without Identified Device or Use Problem 19 19
Excessive Heating 18 18
Power Problem 18 18
Electrical /Electronic Property Problem 18 18
Melted 16 16
Insufficient Device Problem Information 11 11
Electrical Shorting 10 10
Mechanical Problem 9 9
Unexpected Shutdown 9 9
Computer Software Problem 8 8
Noise, Audible 8 8
Blocked Connection 7 7
Device Handling Problem 7 7
Crack 6 6
Loose or Intermittent Connection 6 6
Intermittent Loss of Power 6 6
Sparking 6 6
Material Integrity Problem 5 5
Device Contaminated During Manufacture or Shipping 5 5
Application Program Problem 5 5
Poor Quality Image 5 5
No Display/Image 4 4
Device-Device Incompatibility 4 4
Decoupling 4 4
Loss of Power 4 4
Intermittent Energy Output 4 4
Device Damaged Prior to Use 3 3
Unintended Movement 3 3
Complete Loss of Power 3 3
Appropriate Device Problem Term/Code Not Available 3 3
Device Fell 3 3
Material Separation 3 3
Mechanics Altered 3 3
Flare or Flash 3 3
Failure to Shut Off 3 3
Electrical Power Problem 3 3
Patient Device Interaction Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 801 801
Insufficient Information 77 77
Burn(s) 67 67
Superficial (First Degree) Burn 18 18
No Known Impact Or Consequence To Patient 8 8
Electric Shock 1 1
Unspecified Tissue Injury 1 1
Partial thickness (Second Degree) Burn 1 1
No Consequences Or Impact To Patient 1 1
Abrasion 1 1
Bowel Burn 1 1
Skin Burning Sensation 1 1

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