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TPLC
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show TPLC since
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2022
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Device
lamp, surgical
Product Code
FTD
Regulation Number
878.4580
Device Class
2
MDR Year
MDR Reports
MDR Events
2017
10
10
2018
16
16
2019
80
80
2020
105
105
2021
65
65
2022
35
35
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
125
125
Adverse Event Without Identified Device or Use Problem
72
72
Crack
32
32
Peeled/Delaminated
32
32
Corroded
29
29
Device Fell
12
12
Break
12
12
Disconnection
6
6
Improper or Incorrect Procedure or Method
4
4
Device Operational Issue
4
4
Appropriate Term/Code Not Available
3
3
Temperature Problem
3
3
Detachment Of Device Component
3
3
Fracture
3
3
Component Falling
2
2
Material Erosion
2
2
Device Handling Problem
2
2
Unintended Collision
2
2
Material Integrity Problem
2
2
Fluid Leak
2
2
Sparking
1
1
Device Contamination with Chemical or Other Material
1
1
Sharp Edges
1
1
Excessive Heating
1
1
Misassembly During Maintenance/Repair
1
1
Insufficient Information
1
1
Output Problem
1
1
Device Expiration Issue
1
1
Flaked
1
1
Electrical /Electronic Property Problem
1
1
Contamination
1
1
Intermittent Continuity
1
1
Grounding Malfunction
1
1
Loose or Intermittent Connection
1
1
Moisture Damage
1
1
Pitted
1
1
Failure to Power Up
1
1
Off-Label Use
1
1
Device Slipped
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
105
105
No Clinical Signs, Symptoms or Conditions
86
86
Irritation
25
25
Pain
19
19
No Known Impact Or Consequence To Patient
17
17
Perforation
11
11
No Code Available
7
7
No Patient Involvement
4
4
Radiation Exposure, Unintended
4
4
No Information
4
4
Injury
3
3
Numbness
2
2
Post Operative Wound Infection
2
2
Atrial Perforation
2
2
Cardiac Perforation
2
2
Burn(s)
2
2
Stroke/CVA
2
2
Hemorrhage/Bleeding
2
2
Brain Injury
2
2
Scarring
2
2
Perforation of Vessels
2
2
Great Vessel Perforation
1
1
Scar Tissue
1
1
Discomfort
1
1
Insufficient Information
1
1
Abrasion
1
1
Death
1
1
Laceration(s)
1
1
Muscle Weakness
1
1
Nerve Damage
1
1
Skin Tears
1
1
Burn, Thermal
1
1
Blood Loss
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Maquet Cardiovascular Us Sales, Llc
II
Jun-21-2019
2
Maquet SAS
II
Jul-19-2018
3
Maquet SAS
II
May-25-2018
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