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TPLC
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Device
led light source
Definition
Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals
Product Code
NTN
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
FIBEROPTICS TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
1
MAQUET SAS
SUBSTANTIALLY EQUIVALENT
1
OLYMPUS MEDICAL SYSTEMS CORP.
SUBSTANTIALLY EQUIVALENT
1
OLYMPUS WINTER & IBE GMBH
SUBSTANTIALLY EQUIVALENT
2
OPTIM, INC.
SUBSTANTIALLY EQUIVALENT
1
QUEST MEDICAL IMAGING
SUBSTANTIALLY EQUIVALENT
1
SCHOELLY IMAGING, INC.
SUBSTANTIALLY EQUIVALENT
1
SOPRO
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
1
1
2017
2
2
2020
56
56
2021
47
47
2022
47
47
2023
26
26
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Appropriate Term/Code Not Available
99
99
Optical Problem
86
86
Poor Quality Image
75
75
Unexpected Shutdown
16
16
Adverse Event Without Identified Device or Use Problem
8
8
Connection Problem
8
8
Failure to Power Up
7
7
Overheating of Device
4
4
Use of Device Problem
3
3
Human-Device Interface Problem
3
3
Excessive Heating
2
2
Improper or Incorrect Procedure or Method
2
2
Smoking
2
2
Thermal Decomposition of Device
2
2
Computer Software Problem
1
1
Electrical /Electronic Property Problem
1
1
Fire
1
1
Inadequate Instructions for Healthcare Professional
1
1
Material Separation
1
1
Inadequate or Insufficient Training
1
1
Defective Device
1
1
Detachment of Device or Device Component
1
1
Device Operates Differently Than Expected
1
1
Device-Device Incompatibility
1
1
Inadequate Lighting
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
122
122
No Consequences Or Impact To Patient
55
55
Burn(s)
6
6
Superficial (First Degree) Burn
4
4
No Known Impact Or Consequence To Patient
2
2
No Information
1
1
No Code Available
1
1
Blister
1
1
Insufficient Information
1
1
Bradycardia
1
1
Burn, Thermal
1
1
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