Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
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
541
541
2025
124
124
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
1248
1248
Peeled/Delaminated
888
888
Corroded
320
320
Crack
174
174
Break
86
86
Flaked
78
78
Fluid/Blood Leak
65
65
No Apparent Adverse Event
55
55
Mechanical Problem
55
55
Degraded
54
54
Material Integrity Problem
52
52
Leak/Splash
44
44
Material Erosion
43
43
Fracture
42
42
Material Split, Cut or Torn
34
34
Material Separation
23
23
Insufficient Information
20
20
Grounding Malfunction
18
18
Use of Device Problem
18
18
Device Fell
16
16
Unintended Movement
15
15
Electrical /Electronic Property Problem
11
11
Moisture Damage
10
10
Temperature Problem
8
8
Improper or Incorrect Procedure or Method
6
6
Material Fragmentation
6
6
Overheating of Device
6
6
Failure to Clean Adequately
5
5
Radiation Output Problem
5
5
Unexpected Shutdown
5
5
Radiation Overexposure
5
5
Output Problem
5
5
Pitted
5
5
Appropriate Term/Code Not Available
4
4
Scratched Material
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Contamination /Decontamination Problem
3
3
Excessive Heating
3
3
Device Dislodged or Dislocated
3
3
Smoking
3
3
Naturally Worn
3
3
Unintended Collision
3
3
Component Misassembled
2
2
Device Handling Problem
2
2
Difficult or Delayed Positioning
2
2
Positioning Failure
2
2
Off-Label Use
2
2
Loss of Power
2
2
Loose or Intermittent Connection
2
2
Structural Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1988
1988
No Consequences Or Impact To Patient
389
389
No Patient Involvement
80
80
No Known Impact Or Consequence To Patient
35
35
Burn(s)
20
20
Insufficient Information
17
17
Full thickness (Third Degree) Burn
10
10
Skin Discoloration
6
6
Laceration(s)
5
5
Concussion
5
5
Superficial (First Degree) Burn
5
5
Partial thickness (Second Degree) Burn
5
5
Bruise/Contusion
5
5
Pain
3
3
Scar Tissue
3
3
Foreign Body In Patient
3
3
Abrasion
3
3
Erythema
3
3
Injury
2
2
Skin Tears
2
2
Eye Injury
2
2
Headache
2
2
Burning Sensation
1
1
No Code Available
1
1
Bone Fracture(s)
1
1
Head Injury
1
1
Hematoma
1
1
Muscle/Tendon Damage
1
1
Unspecified Tissue Injury
1
1
Swelling/ Edema
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
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
-
-