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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


Premarket Reviews
ManufacturerDecision
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
NOVAPROBE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
OLIVE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUNOPTIC TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 11 11
2015 23 23
2016 29 29
2017 59 59
2018 76 76
2019 118 118
2020 152 152
2021 147 147
2022 166 166
2023 179 179
2024 70 70

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 166 166
Overheating of Device 152 152
Smoking 92 92
Temperature Problem 81 81
Circuit Failure 77 77
Device Emits Odor 71 71
Electrical /Electronic Property Problem 56 56
Thermal Decomposition of Device 54 54
Display or Visual Feedback Problem 52 52
Adverse Event Without Identified Device or Use Problem 42 42
No Display/Image 41 41
Melted 39 39
Failure to Power Up 37 37
Break 33 33
Power Problem 30 30
Poor Quality Image 27 27
Loss of Power 23 23
Fire 20 20
Intermittent Continuity 19 19
Intermittent Loss of Power 17 17
Sparking 16 16
Detachment of Device or Device Component 16 16
Optical Problem 15 15
Use of Device Problem 13 13
Device Operates Differently Than Expected 11 11
Mechanical Problem 11 11
Unexpected Shutdown 9 9
Excessive Heating 9 9
Insufficient Information 7 7
Device Contaminated During Manufacture or Shipping 7 7
Noise, Audible 7 7
Loose or Intermittent Connection 7 7
Connection Problem 7 7
Electrical Shorting 6 6
Failure to Shut Off 6 6
No Device Output 6 6
Crack 6 6
Computer Software Problem 6 6
Flare or Flash 5 5
Environmental Particulates 5 5
Device Dislodged or Dislocated 5 5
Electrical Power Problem 4 4
Environmental Compatibility Problem 4 4
Energy Output Problem 4 4
Appropriate Term/Code Not Available 4 4
Device Fell 4 4
Material Integrity Problem 3 3
Erratic or Intermittent Display 3 3
Disconnection 3 3
Component Falling 3 3
Device-Device Incompatibility 3 3
Application Program Problem 3 3
Blocked Connection 3 3
Improper or Incorrect Procedure or Method 3 3
Device Inoperable 3 3
Defective Device 3 3
Device Displays Incorrect Message 3 3
Device Damaged Prior to Use 3 3
Device Sensing Problem 2 2
Arcing 2 2
Activation, Positioning or Separation Problem 2 2
Unintended Power Up 2 2
Material Discolored 2 2
Output above Specifications 2 2
Hole In Material 2 2
Light Interference 2 2
Human-Device Interface Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Complete Loss of Power 2 2
Device Handling Problem 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
Reset Problem 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Inadequate Lighting 1 1
Mechanical Jam 1 1
Optical Obstruction 1 1
Image Display Error/Artifact 1 1
Material Frayed 1 1
Peeled/Delaminated 1 1
Power Conditioning Problem 1 1
Positioning Failure 1 1
Material Disintegration 1 1
Component Incompatible 1 1
Detachment Of Device Component 1 1
Device Alarm System 1 1
No Audible Alarm 1 1
Component or Accessory Incompatibility 1 1
Loss of Data 1 1
Device Contamination with Chemical or Other Material 1 1
Defective Component 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 524 524
No Known Impact Or Consequence To Patient 237 237
No Consequences Or Impact To Patient 133 133
Insufficient Information 67 67
Burn(s) 61 61
No Patient Involvement 26 26
Burn, Thermal 17 17
Superficial (First Degree) Burn 15 15
Not Applicable 11 11
No Information 8 8
Injury 5 5
Partial thickness (Second Degree) Burn 4 4
No Code Available 3 3
Full thickness (Third Degree) Burn 2 2
Patient Problem/Medical Problem 2 2
Unspecified Tissue Injury 1 1
Foreign Body In Patient 1 1
Electric Shock 1 1
Abrasion 1 1
Discharge 1 1
Erythema 1 1
Scarring 1 1
Shock 1 1
Swelling 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Dec-02-2011
2 Integra LifeSciences Corp. II Apr-25-2011
3 Stryker Corporation II Apr-28-2023
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