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TPLC
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show TPLC since
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2024
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Device
accessories, photographic, for endoscope (exclude light sources)
Product Code
FEM
Regulation Number
876.1500
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
8
8
2015
5
5
2016
9
9
2017
14
14
2018
15
15
2019
22
22
2020
54
54
2021
47
47
2022
109
109
2023
131
131
2024
62
62
Device Problems
MDRs with this Device Problem
Events in those MDRs
Display or Visual Feedback Problem
185
185
Break
135
135
Sparking
25
25
Moisture Damage
24
24
Detachment of Device or Device Component
21
21
Smoking
17
17
Device-Device Incompatibility
16
16
Thermal Decomposition of Device
12
12
Mechanical Problem
12
12
Unintended Movement
11
11
Use of Device Problem
11
11
Loss of Power
10
10
Device Contaminated During Manufacture or Shipping
9
9
Fire
9
9
Difficult to Open or Close
9
9
Melted
8
8
Material Deformation
8
8
Degraded
8
8
Detachment Of Device Component
6
6
Failure to Power Up
6
6
Device Operational Issue
6
6
Poor Quality Image
5
5
Device Damaged Prior to Use
5
5
Device Fell
5
5
Device Emits Odor
5
5
Corroded
4
4
Mechanical Jam
4
4
Electrical /Electronic Property Problem
4
4
Loose or Intermittent Connection
4
4
Scratched Material
4
4
Overheating of Device
4
4
Appropriate Term/Code Not Available
4
4
Device Operates Differently Than Expected
4
4
Crack
4
4
Insufficient Information
4
4
Disconnection
3
3
Electrical Power Problem
3
3
Contamination /Decontamination Problem
3
3
Defective Component
3
3
Difficult or Delayed Separation
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Temperature Problem
3
3
Unintended Collision
3
3
Defective Device
3
3
Power Problem
2
2
Fracture
2
2
Lack of Maintenance Documentation or Guidelines
2
2
Device Contamination with Chemical or Other Material
2
2
Difficult to Advance
2
2
Battery Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
341
341
No Known Impact Or Consequence To Patient
38
38
No Consequences Or Impact To Patient
37
37
No Information
33
33
No Patient Involvement
20
20
Injury
7
7
Insufficient Information
7
7
Not Applicable
6
6
Unspecified Tissue Injury
4
4
Electric Shock
3
3
Bruise/Contusion
3
3
Patient Problem/Medical Problem
2
2
Shock
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Code Available
1
1
Bowel Perforation
1
1
Sprain
1
1
Burn, Thermal
1
1
Burn(s)
1
1
Swelling
1
1
Numbness
1
1
Laceration(s)
1
1
Pain
1
1
Hyperextension
1
1
Swelling/ Edema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ambu Inc.
II
Sep-22-2023
2
Olympus America Inc.
II
Mar-05-2012
3
Olympus Corporation of the Americas
II
Jul-17-2019
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