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TPLC
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show TPLC since
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2024
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Device
lamp, surgical
Product Code
FTD
Regulation Number
878.4580
Device Class
2
MDR Year
MDR Reports
MDR Events
2018
16
16
2019
80
80
2020
105
105
2021
65
65
2022
136
136
2023
260
260
2024
132
132
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
470
470
Peeled/Delaminated
154
154
Crack
103
103
Adverse Event Without Identified Device or Use Problem
70
70
Corroded
63
63
Fluid/Blood Leak
48
48
Fracture
31
31
Device Fell
27
27
Break
15
15
No Apparent Adverse Event
10
10
Material Split, Cut or Torn
9
9
Disconnection
8
8
Leak/Splash
7
7
Improper or Incorrect Procedure or Method
5
5
Flaked
5
5
Device Operational Issue
4
4
Temperature Problem
4
4
Positioning Failure
3
3
Appropriate Term/Code Not Available
3
3
Material Disintegration
3
3
Unexpected Shutdown
3
3
Loose or Intermittent Connection
3
3
Grounding Malfunction
2
2
Material Integrity Problem
2
2
Detachment Of Device Component
2
2
Difficult to Advance
2
2
Material Erosion
2
2
Unintended Collision
2
2
Contamination
2
2
Scratched Material
2
2
Moisture Damage
2
2
Difficult or Delayed Positioning
2
2
Structural Problem
2
2
Unintended Electrical Shock
2
2
Use of Device Problem
2
2
Intermittent Continuity
1
1
Mechanics Altered
1
1
Misassembly During Maintenance/Repair
1
1
Sharp Edges
1
1
Material Twisted/Bent
1
1
Electrical /Electronic Property Problem
1
1
Failure to Power Up
1
1
Degraded
1
1
Output Problem
1
1
Off-Label Use
1
1
Misassembled
1
1
Device Handling Problem
1
1
Pitted
1
1
Component Falling
1
1
Overheating of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
562
562
No Consequences Or Impact To Patient
105
105
Irritation
25
25
Pain
19
19
No Known Impact Or Consequence To Patient
13
13
Perforation
11
11
No Code Available
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Hemorrhage/Bleeding
5
5
Radiation Exposure, Unintended
4
4
No Patient Involvement
4
4
No Information
3
3
Burn(s)
3
3
Cardiac Perforation
3
3
Numbness
3
3
Insufficient Information
3
3
Skin Tears
3
3
Stroke/CVA
2
2
Brain Injury
2
2
Scarring
2
2
Post Operative Wound Infection
2
2
Injury
2
2
Death
1
1
Head Injury
1
1
Muscle Weakness
1
1
Abrasion
1
1
Burn, Thermal
1
1
Nerve Damage
1
1
Discomfort
1
1
Laceration(s)
1
1
Scar Tissue
1
1
Perforation of Vessels
1
1
Great Vessel Perforation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Jul-05-2024
2
Getinge Usa Sales Inc
II
Jan-19-2024
3
Maquet Cardiovascular Us Sales, Llc
II
Jun-21-2019
4
Maquet SAS
II
Jul-19-2018
5
Maquet SAS
II
May-25-2018
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