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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device microscope, surgical
Product CodeEPT
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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