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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
microscope, surgical
Product Code
EPT
Regulation Number
878.4700
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
15
15
2020
10
10
2021
31
31
2022
42
42
2023
44
44
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Electrical /Electronic Property Problem
70
70
Material Split, Cut or Torn
13
13
Adverse Event Without Identified Device or Use Problem
8
8
Detachment of Device or Device Component
7
7
Intermittent Loss of Power
6
6
Unexpected Shutdown
6
6
Device Tipped Over
6
6
Device Dislodged or Dislocated
5
5
Device Fell
4
4
Insufficient Information
4
4
Use of Device Problem
4
4
Break
4
4
Mechanical Problem
3
3
Defective Device
3
3
Circuit Failure
2
2
Overheating of Device
2
2
Noise, Audible
2
2
Optical Problem
2
2
Optical Obstruction
2
2
Therapeutic or Diagnostic Output Failure
1
1
Unintended Movement
1
1
Environmental Particulates
1
1
Device Contamination with Chemical or Other Material
1
1
Naturally Worn
1
1
Explosion
1
1
Activation Problem
1
1
Failure to Clean Adequately
1
1
Material Separation
1
1
Unexpected Therapeutic Results
1
1
Unstable
1
1
Vibration
1
1
Sparking
1
1
Insufficient Cooling
1
1
Degraded
1
1
Display or Visual Feedback Problem
1
1
Melted
1
1
Misfocusing
1
1
Fracture
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
111
111
No Known Impact Or Consequence To Patient
16
16
Partial thickness (Second Degree) Burn
8
8
Burn(s)
4
4
No Consequences Or Impact To Patient
4
4
Superficial (First Degree) Burn
2
2
Burn, Thermal
2
2
Capsular Bag Tear
1
1
Syncope/Fainting
1
1
Intraocular Pressure Decreased
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Injury
1
1
Abrasion
1
1
Bruise/Contusion
1
1
Crushing Injury
1
1
Head Injury
1
1
Headache
1
1
Hemorrhage/Bleeding
1
1
Nausea
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Haag-Streit USA Inc
II
Sep-05-2019
2
Leica Microsystems, Inc.
II
Dec-09-2022
3
Leica Microsystems, Inc.
II
Jun-17-2020
-
-