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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device battery, replacement, rechargeable
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeMOQ
Regulation Number 878.4820
Device Class 1

Device Problems
Unintended System Motion 452
Fail-Safe Problem 441
Device Inoperable 103
Failure to Charge 83
Device Operates Differently Than Expected 71
Overheating of Device 58
Charging Problem 34
Battery Charger 30
Battery Problem 29
Unexpected Shutdown 20
Fluid Leak 17
Break 17
Battery 16
Failure to Power Up 14
Noise, Audible 14
Device Displays Incorrect Message 12
Mechanical Problem 12
Crack 11
Mechanical Jam 9
Detachment Of Device Component 7
Defective Component 7
Defective Device 6
Smoking 6
Complete Loss of power 6
Loss of Power 5
Output below Specifications 5
Housing 5
Device Operational Issue 5
Loose or Intermittent Connection 4
No Display / Image 4
Melted 4
LED (Light Emitting Diode) 4
Component Falling 4
Material Deformation 3
Bent 3
Device Stops Intermittently 3
Fire 3
Temperature Problem 3
Connection Problem 2
Visual Prompts will not Clear 2
Corroded 2
Component Missing 2
Fumes or Vapors 2
Separation Failure 2
Detachment of Device or device Component 2
Electrical /Electronic Property Problem 2
Device Emits Odor 2
Port 2
Device Damaged by Another Device 2
Failure to Deliver Energy 2
Power Problem 2
Torn Material 2
Locking Mechanism 2
Vibration 2
Flare or Flash 2
Power Module 2
Power Conditioning Problem 2
Component Incompatible 1
Premature Separation 1
Computer Operating System Problem 1
Use of Device Problem 1
Charger 1
Power Supply 1
Failure of Device to Self-Test 1
Unintended Ejection 1
Holder 1
Premature Discharge of Battery 1
Sticking 1
Dent in Material 1
Low Battery 1
Delayed Charge Time 1
Unstable 1
No Fail-Safe Mechanism 1
Fan 1
Explosion 1
Switch, Push Button 1
Difficult to Open or Close 1
Appropriate Term/Code Not Available 1
Circuit Failure 1
Fracture 1
Leak / Splash 1
Difficult To Position 1
Aborted Charge 1
Unintended Head Motion 1
Moisture Damage 1
Device Slipped 1
Sparking 1
Device Subassembly 1
Handpiece 1
Total Device Problems 1600

Recalls
Manufacturer Recall Class Date Posted
1 Pro-Dex Inc II Mar-11-2016
2 The Anspach Effort, Inc. II Jul-05-2016
3 The Anspach Effort, Inc. II Jun-15-2016

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