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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 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
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