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TPLC
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show TPLC since
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Device
light, surgical, ceiling mounted
Product Code
FSY
Regulation Number
878.4580
Device Class
2
MDR Year
MDR Reports
MDR Events
2018
316
316
2019
444
444
2020
439
439
2021
380
380
2022
430
430
2023
422
422
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
987
987
Peeled/Delaminated
602
602
Corroded
249
249
Crack
202
202
Degraded
140
140
Flaked
130
130
Material Integrity Problem
115
115
Break
111
111
Mechanical Problem
102
102
Material Fragmentation
76
76
Device Fell
73
73
Material Erosion
42
42
Leak/Splash
36
36
Component Falling
28
28
Fluid/Blood Leak
24
24
Fracture
21
21
No Apparent Adverse Event
18
18
Material Separation
17
17
Grounding Malfunction
16
16
Detachment Of Device Component
15
15
Temperature Problem
14
14
Unintended Movement
13
13
Component Missing
13
13
Device Issue
13
13
Electrical /Electronic Property Problem
12
12
Use of Device Problem
11
11
Material Disintegration
10
10
Appropriate Term/Code Not Available
9
9
Adverse Event Without Identified Device or Use Problem
9
9
Physical Property Issue
8
8
Material Split, Cut or Torn
8
8
Loose or Intermittent Connection
8
8
Improper or Incorrect Procedure or Method
7
7
Smoking
7
7
Device Dislodged or Dislocated
7
7
Overheating of Device
6
6
Burst Container or Vessel
5
5
Contamination /Decontamination Problem
5
5
Structural Problem
5
5
Defective Device
5
5
Pitted
5
5
Radiation Overexposure
5
5
Radiation Output Problem
5
5
Output Problem
5
5
Insufficient Information
5
5
Misassembly During Maintenance/Repair
4
4
Defective Component
4
4
Contamination
4
4
Unintended Collision
4
4
Moisture Damage
4
4
Particulates
3
3
Loss of Power
3
3
Device Contamination with Chemical or Other Material
3
3
Installation-Related Problem
3
3
Device Damaged by Another Device
3
3
Failure to Clean Adequately
3
3
Unexpected Shutdown
3
3
Patient Device Interaction Problem
2
2
Component Misassembled
2
2
Separation Problem
2
2
Device Handling Problem
2
2
Naturally Worn
2
2
Power Problem
2
2
Protective Measures Problem
2
2
Material Deformation
2
2
Device Operates Differently Than Expected
2
2
Sparking
2
2
Off-Label Use
2
2
Tear, Rip or Hole in Device Packaging
2
2
Misassembled
2
2
Device Emits Odor
1
1
No Device Output
1
1
Melted
1
1
Circuit Failure
1
1
Thermal Decomposition of Device
1
1
Accessory Incompatible
1
1
Unintended Arm Motion
1
1
Bent
1
1
Fire
1
1
Material Discolored
1
1
Decoupling
1
1
Device Tipped Over
1
1
Separation Failure
1
1
Device Damaged Prior to Use
1
1
Device Slipped
1
1
Battery Problem
1
1
Component or Accessory Incompatibility
1
1
Connection Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Inadequate Lighting
1
1
Compatibility Problem
1
1
Environmental Compatibility Problem
1
1
Positioning Problem
1
1
Activation Failure
1
1
Misassembly by Users
1
1
Torn Material
1
1
Misassembled During Installation
1
1
Inadequate Lubrication
1
1
Ejection Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1124
1124
No Consequences Or Impact To Patient
579
579
No Known Impact Or Consequence To Patient
508
508
No Patient Involvement
154
154
Injury
17
17
Burn(s)
13
13
Insufficient Information
12
12
No Information
10
10
Bruise/Contusion
6
6
Skin Discoloration
5
5
No Code Available
4
4
Foreign Body In Patient
3
3
Concussion
3
3
Burn, Thermal
3
3
Tissue Damage
2
2
Eye Injury
2
2
Laceration(s)
2
2
Head Injury
2
2
Headache
2
2
Patient Problem/Medical Problem
2
2
Superficial (First Degree) Burn
2
2
Full thickness (Third Degree) Burn
1
1
Device Embedded In Tissue or Plaque
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Hematoma
1
1
Inflammation
1
1
Pain
1
1
Bone Fracture(s)
1
1
Swelling
1
1
Skin Tears
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
GETINGE US SALES LLC
II
Mar-07-2019
2
GETINGE US SALES LLC
II
Apr-10-2018
3
GETINGE US SALES LLC
II
Mar-05-2018
4
Getinge Usa Sales Inc
II
Jun-30-2022
5
Stryker Communications
II
Mar-27-2020
6
Stryker Communications
II
Sep-12-2019
7
Stryker Communications
II
Aug-30-2019
8
Stryker Communications
II
May-21-2019
9
Stryker Communications
II
Mar-01-2018
10
Stryker Communications
II
Feb-23-2018
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