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TPLC
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show TPLC since
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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
16
16
Device Problems
MDRs with this Device Problem
Events in those MDRs
Electrical /Electronic Property Problem
74
74
Material Split, Cut or Torn
14
14
Adverse Event Without Identified Device or Use Problem
9
9
Device Tipped Over
8
8
Detachment of Device or Device Component
8
8
Intermittent Loss of Power
6
6
Unexpected Shutdown
6
6
Use of Device Problem
6
6
Insufficient Information
5
5
Device Dislodged or Dislocated
5
5
Break
4
4
Device Fell
4
4
Mechanical Problem
3
3
Defective Device
3
3
Noise, Audible
2
2
Optical Obstruction
2
2
Overheating of Device
2
2
Optical Problem
2
2
Circuit Failure
2
2
Fogging
1
1
Degraded
1
1
Failure to Clean Adequately
1
1
Product Quality Problem
1
1
Material Separation
1
1
Therapeutic or Diagnostic Output Failure
1
1
Environmental Particulates
1
1
Device Contamination with Chemical or Other Material
1
1
Explosion
1
1
Fracture
1
1
Vibration
1
1
Melted
1
1
Unexpected Therapeutic Results
1
1
Naturally Worn
1
1
Insufficient Cooling
1
1
Unintended Movement
1
1
Activation Problem
1
1
Display or Visual Feedback Problem
1
1
Sparking
1
1
Loose or Intermittent Connection
1
1
Mechanical Jam
1
1
Unstable
1
1
Misfocusing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
119
119
No Known Impact Or Consequence To Patient
16
16
Partial thickness (Second Degree) Burn
8
8
Burn(s)
5
5
No Consequences Or Impact To Patient
4
4
Superficial (First Degree) Burn
2
2
Burn, Thermal
2
2
Bruise/Contusion
2
2
Syncope/Fainting
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Nausea
1
1
Head Injury
1
1
Abrasion
1
1
Crushing Injury
1
1
Capsular Bag Tear
1
1
Injury
1
1
Insufficient Information
1
1
Intraocular Pressure Decreased
1
1
Headache
1
1
Hemorrhage/Bleeding
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
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