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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
2019
80
80
2020
105
105
2021
65
65
2022
136
136
2023
260
260
2024
53
53
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
413
413
Peeled/Delaminated
127
127
Crack
89
89
Adverse Event Without Identified Device or Use Problem
64
64
Corroded
56
56
Fluid/Blood Leak
48
48
Fracture
31
31
Device Fell
21
21
Break
13
13
Disconnection
7
7
Leak/Splash
7
7
Material Split, Cut or Torn
6
6
No Apparent Adverse Event
5
5
Temperature Problem
4
4
Device Operational Issue
4
4
Improper or Incorrect Procedure or Method
4
4
Flaked
4
4
Loose or Intermittent Connection
3
3
Material Disintegration
3
3
Positioning Failure
3
3
Appropriate Term/Code Not Available
3
3
Unexpected Shutdown
3
3
Unintended Electrical Shock
2
2
Difficult or Delayed Positioning
2
2
Moisture Damage
2
2
Unintended Collision
2
2
Material Erosion
2
2
Structural Problem
2
2
Scratched Material
2
2
Difficult to Advance
2
2
Material Integrity Problem
1
1
Mechanics Altered
1
1
Output Problem
1
1
Power Problem
1
1
Insufficient Information
1
1
Sparking
1
1
Device-Device Incompatibility
1
1
Pitted
1
1
Unstable
1
1
Use of Device Problem
1
1
Grounding Malfunction
1
1
Overheating of Device
1
1
Misassembled
1
1
Contamination
1
1
Electrical /Electronic Property Problem
1
1
Excessive Heating
1
1
Misassembly During Maintenance/Repair
1
1
Device Handling Problem
1
1
Sharp Edges
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
481
481
No Consequences Or Impact To Patient
102
102
Irritation
25
25
Pain
19
19
No Known Impact Or Consequence To Patient
10
10
No Code Available
7
7
Perforation
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
No Patient Involvement
4
4
Radiation Exposure, Unintended
4
4
Hemorrhage/Bleeding
4
4
Burn(s)
3
3
Numbness
3
3
Skin Tears
3
3
Insufficient Information
3
3
No Information
2
2
Post Operative Wound Infection
2
2
Cardiac Perforation
2
2
Brain Injury
2
2
Stroke/CVA
2
2
Abrasion
1
1
Laceration(s)
1
1
Muscle Weakness
1
1
Nerve Damage
1
1
Discomfort
1
1
Scar Tissue
1
1
Scarring
1
1
Perforation of Vessels
1
1
Great Vessel Perforation
1
1
Burn, Thermal
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Getinge Usa Sales Inc
II
Jan-19-2024
2
Maquet Cardiovascular Us Sales, Llc
II
Jun-21-2019
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