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TPLC
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Device
confocal optical imaging
Definition
Collection of light signals for visualization of cellular microstructures.
Product Code
OWN
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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