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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device microscope, surgical, general & plastic surgery
Product CodeFSO
Regulation Number 878.4700
Device Class 1

MDR Year MDR Reports MDR Events
2017 14 14
2018 11 11
2019 12 12
2020 7 7
2021 19 19
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 16 16
Installation-Related Problem 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Device Dislodged or Dislocated 6 6
Unstable 6 6
Use of Device Problem 5 5
Detachment of Device or Device Component 4 4
Break 3 3
Detachment Of Device Component 3 3
Component Falling 3 3
Mechanical Problem 3 3
Unexpected Shutdown 3 3
No Apparent Adverse Event 2 2
Misfocusing 2 2
Computer Software Problem 2 2
Cut In Material 2 2
Device Operates Differently Than Expected 2 2
Optical Problem 2 2
Device Handling Problem 2 2
Noise, Audible 2 2
Patient Device Interaction Problem 2 2
Physical Resistance/Sticking 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Reset Problem 1 1
Device Operational Issue 1 1
Bent 1 1
Operating System Becomes Nonfunctional 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Failure to Align 1 1
Device Displays Incorrect Message 1 1
Connection Problem 1 1
Vibration 1 1
Improper or Incorrect Procedure or Method 1 1
Use of Incorrect Control Settings 1 1
Display or Visual Feedback Problem 1 1
Loose or Intermittent Connection 1 1
Product Quality Problem 1 1
Device Inoperable 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Unintended Electrical Shock 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Misassembly During Maintenance/Repair 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
No Known Impact Or Consequence To Patient 15 15
No Patient Involvement 7 7
Partial thickness (Second Degree) Burn 4 4
Electric Shock 3 3
Insufficient Information 3 3
Laceration(s) 3 3
No Consequences Or Impact To Patient 2 2
Bruise/Contusion 2 2
Full thickness (Third Degree) Burn 2 2
No Information 2 2
No Code Available 1 1
Superficial (First Degree) Burn 1 1
Burn(s) 1 1
Stroke/CVA 1 1
Bone Fracture(s) 1 1
Hemorrhage/Bleeding 1 1
Burn, Thermal 1 1
Swelling 1 1
Tinnitus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Leica Microsystems, Inc. II Dec-22-2021
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