Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 163 163
Overheating of Device 151 151
Smoking 89 89
Temperature Problem 80 80
Device Emits Odor 70 70
Circuit Failure 67 67
Electrical /Electronic Property Problem 56 56
Thermal Decomposition of Device 54 54
Display or Visual Feedback Problem 49 49
Adverse Event Without Identified Device or Use Problem 42 42
No Display/Image 40 40
Melted 38 38
Failure to Power Up 33 33
Break 32 32
Power Problem 29 29
Poor Quality Image 27 27
Loss of Power 23 23
Fire 20 20
Intermittent Continuity 19 19
Sparking 16 16
Detachment of Device or Device Component 16 16
Optical Problem 15 15
Intermittent Loss of Power 15 15
Device Operates Differently Than Expected 11 11
Use of Device Problem 11 11
Mechanical Problem 11 11
Unexpected Shutdown 9 9
Excessive Heating 8 8
Insufficient Information 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
Computer Software Problem 6 6
Crack 5 5
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
Device Contaminated During Manufacture or Shipping 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
Defective Device 3 3
Device Displays Incorrect Message 3 3
Device Inoperable 3 3
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
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
Mechanics Altered 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
Device Sensing Problem 1 1
Component or Accessory Incompatibility 1 1
Loss of Data 1 1
Device Contamination with Chemical or Other Material 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Ambient Noise Problem 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 237 237
No Consequences Or Impact To Patient 133 133
Insufficient Information 67 67
Burn(s) 60 60
No Patient Involvement 26 26
Burn, Thermal 17 17
Superficial (First Degree) Burn 14 14
Not Applicable 11 11
No Information 8 8
Injury 5 5
Partial thickness (Second Degree) Burn 4 4
No Code Available 3 3
Patient Problem/Medical Problem 2 2
Full thickness (Third Degree) Burn 2 2
Foreign Body In Patient 1 1
Unspecified Tissue Injury 1 1
Electric Shock 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
-
-