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TPLC
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show TPLC since
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Device
light, surgical, ceiling mounted
Regulation Description
Surgical lamp.
Product Code
FSY
Regulation Number
878.4580
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
439
439
2021
380
380
2022
430
430
2023
663
663
2024
540
540
2025
33
33
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
1216
1216
Peeled/Delaminated
841
841
Corroded
308
308
Crack
160
160
Break
81
81
Flaked
78
78
Fluid/Blood Leak
56
56
Mechanical Problem
55
55
Degraded
54
54
No Apparent Adverse Event
54
54
Material Integrity Problem
52
52
Leak/Splash
44
44
Material Erosion
42
42
Fracture
41
41
Material Split, Cut or Torn
30
30
Material Separation
22
22
Insufficient Information
19
19
Grounding Malfunction
18
18
Device Fell
16
16
Use of Device Problem
16
16
Unintended Movement
14
14
Electrical /Electronic Property Problem
11
11
Moisture Damage
9
9
Temperature Problem
8
8
Overheating of Device
6
6
Pitted
5
5
Radiation Output Problem
5
5
Failure to Clean Adequately
5
5
Output Problem
5
5
Unexpected Shutdown
5
5
Improper or Incorrect Procedure or Method
5
5
Material Fragmentation
5
5
Radiation Overexposure
5
5
Adverse Event Without Identified Device or Use Problem
4
4
Appropriate Term/Code Not Available
4
4
Scratched Material
4
4
Unintended Collision
3
3
Naturally Worn
3
3
Contamination /Decontamination Problem
3
3
Smoking
3
3
Device Dislodged or Dislocated
3
3
Device Handling Problem
2
2
Difficult or Delayed Positioning
2
2
Tear, Rip or Hole in Device Packaging
2
2
Structural Problem
2
2
Installation-Related Problem
2
2
Loose or Intermittent Connection
2
2
Defective Component
2
2
Component Missing
2
2
Off-Label Use
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1901
1901
No Consequences Or Impact To Patient
389
389
No Patient Involvement
80
80
No Known Impact Or Consequence To Patient
35
35
Burn(s)
19
19
Insufficient Information
17
17
Full thickness (Third Degree) Burn
9
9
Bruise/Contusion
5
5
Superficial (First Degree) Burn
5
5
Laceration(s)
5
5
Partial thickness (Second Degree) Burn
5
5
Skin Discoloration
5
5
Concussion
5
5
Abrasion
3
3
Scar Tissue
3
3
Foreign Body In Patient
3
3
Erythema
3
3
Skin Tears
2
2
Injury
2
2
Pain
2
2
Eye Injury
2
2
Headache
2
2
Unspecified Tissue Injury
1
1
Burning Sensation
1
1
Hematoma
1
1
Head Injury
1
1
Swelling/ Edema
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Code Available
1
1
Bone Fracture(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DKK Dai-Ichi Shomei Co., Ltd.
II
Aug-14-2024
2
DKK Dai-Ichi Shomei Co., Ltd.
II
Oct-06-2023
3
Getinge Usa Sales Inc
II
Jan-19-2024
4
Getinge Usa Sales Inc
II
Jun-30-2022
5
Stryker Communications
II
Apr-09-2024
6
Stryker Communications
II
Mar-27-2020
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