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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
Regulation Description Surgical microscope and accessories.
Product CodeFSO
Regulation Number 878.4700
Device Class 1

Device Problems
Adverse Event Without Identified Device or Use Problem 14
Device Fell 8
Installation-Related Problem 8
Device Dislodged or Dislocated 6
Unstable 6
Component Falling 5
Detachment Of Device Component 5
Use of Device Problem 4
Bent 3
Mechanical Problem 3
Device Operates Differently Than Expected 3
Electrical /Electronic Property Problem 3
Detachment of Device or Device Component 3
Failure to Conduct 2
Device Maintenance Issue 2
Misfocusing 2
Cut In Material 2
Break 2
Device Handling Problem 2
Patient Device Interaction Problem 1
Optical Problem 1
Vibration 1
Use of Incorrect Control Settings 1
Fluid Leak 1
Mechanical Jam 1
Improper or Incorrect Procedure or Method 1
Device Operational Issue 1
Circuit Failure 1
Failure To Service 1
Appropriate Term/Code Not Available 1
Disconnection 1
Invalid Sensing 1
Device Displays Incorrect Message 1
Physical Resistance/Sticking 1
Total Device Problems 98

Recalls
Manufacturer Recall Class Date Posted
1 Leica Microsystems, Inc. II Apr-15-2016

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