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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device confocal optical imaging
Definition Collection of light signals for visualization of cellular microstructures.
Product CodeOWN
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ACTIV SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY- AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY_AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ-ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAUNA KEA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 7
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
NOVADAQ TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVADAQ TECHNOLOGIES ULC (NOW A PART OF STRYKER)
  SUBSTANTIALLY EQUIVALENT 1
NOVADAQ TECHNOLOGIES ULC. (NOW A PART OF STRYKER)
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 3
VISIONSENSE LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 12 12
2018 11 11
2019 59 59
2020 105 105
2021 312 312
2022 109 109

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 254 254
Communication or Transmission Problem 90 90
Output Problem 57 57
Poor Quality Image 51 51
Electrical /Electronic Property Problem 50 50
Adverse Event Without Identified Device or Use Problem 30 30
Erratic or Intermittent Display 24 24
Failure to Power Up 23 23
Break 17 17
Display or Visual Feedback Problem 17 17
Loss of Power 13 13
Thermal Decomposition of Device 12 12
Temperature Problem 12 12
Defective Component 9 9
Optical Problem 8 8
Failure to Shut Off 8 8
Power Problem 7 7
Therapeutic or Diagnostic Output Failure 7 7
Overheating of Device 7 7
Insufficient Information 6 6
Device Operates Differently Than Expected 6 6
Material Integrity Problem 5 5
Energy Output Problem 5 5
No Device Output 5 5
Image Display Error/Artifact 5 5
Intermittent Loss of Power 5 5
Activation Problem 4 4
Excessive Heating 4 4
Crack 4 4
Contamination /Decontamination Problem 4 4
Optical Obstruction 4 4
Defective Device 4 4
Sparking 3 3
Application Program Problem 3 3
Activation, Positioning or SeparationProblem 3 3
Output below Specifications 3 3
Environmental Compatibility Problem 3 3
Material Twisted/Bent 3 3
Device Reprocessing Problem 3 3
Product Quality Problem 3 3
Activation Failure 3 3
Unexpected Shutdown 2 2
Component Missing 2 2
Nonstandard Device 2 2
Material Opacification 2 2
Mechanical Problem 2 2
Misfocusing 2 2
Device Alarm System 2 2
Fluid Leak 2 2
Fogging 2 2
Optical Distortion 2 2
Inadequate Lighting 2 2
Appropriate Term/Code Not Available 2 2
Connection Problem 2 2
Device Damaged by Another Device 2 2
Device Dislodged or Dislocated 2 2
Biocompatibility 2 2
Patient-Device Incompatibility 2 2
Device Displays Incorrect Message 2 2
Failure to Sense 2 2
Inappropriate/Inadequate Shock/Stimulation 1 1
Use of Device Problem 1 1
Electrical Power Problem 1 1
Device-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Mechanical Jam 1 1
Loose or Intermittent Connection 1 1
False Positive Result 1 1
Signal Artifact/Noise 1 1
Circuit Failure 1 1
Computer Software Problem 1 1
Low Readings 1 1
Failure to Disconnect 1 1
Difficult or Delayed Activation 1 1
Self-Activation or Keying 1 1
Material Puncture/Hole 1 1
Intermittent Energy Output 1 1
Noise, Audible 1 1
Fail-Safe Did Not Operate 1 1
Missing Information 1 1
Key or Button Unresponsive/not Working 1 1
Application Program Freezes, Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 428 428
No Known Impact Or Consequence To Patient 106 106
No Consequences Or Impact To Patient 79 79
Insufficient Information 54 54
Burn, Thermal 12 12
No Patient Involvement 10 10
Burn(s) 8 8
Superficial (First Degree) Burn 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Electric Shock 2 2
Death 1 1
Partial thickness (Second Degree) Burn 1 1
No Information 1 1
No Code Available 1 1
Patient Problem/Medical Problem 1 1

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