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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

MDR Year MDR Reports MDR Events
2016 363 363
2017 507 507
2018 133 133
2019 78 78
2020 120 120
2021 104 104

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 464 464
Fail-Safe Problem 443 443
Battery Problem 131 131
Device Operates Differently Than Expected 105 105
Device Inoperable 98 98
Break 90 90
Overheating of Device 68 68
Complete Loss of Power 46 46
Failure to Charge 41 41
Defective Component 35 35
Vibration 33 33
Mechanical Jam 27 27
Charging Problem 26 26
Mechanical Problem 23 23
Defective Device 22 22
Appropriate Term/Code Not Available 22 22
Unexpected Shutdown 20 20
Leak/Splash 20 20
Fluid Leak 19 19
Noise, Audible 18 18
Thermal Decomposition of Device 15 15
Device Displays Incorrect Message 14 14
Melted 13 13
Fire 12 12
Temperature Problem 12 12
Smoking 11 11
Crack 10 10
Naturally Worn 10 10
Loose or Intermittent Connection 10 10
Electrical /Electronic Property Problem 9 9
Detachment Of Device Component 8 8
Component Falling 8 8
Output below Specifications 8 8
Premature Separation 7 7
Fail-Safe Did Not Operate 6 6
Self-Activation or Keying 6 6
Partial Blockage 5 5
Material Deformation 5 5
Device Operational Issue 5 5
Torn Material 5 5
Fracture 5 5
Bent 5 5
Device Stops Intermittently 4 4
Premature Discharge of Battery 4 4
Moisture Damage 4 4
Sticking 3 3
Device-Device Incompatibility 3 3
Failure of Device to Self-Test 3 3
Excessive Heating 3 3
Scratched Material 3 3
Loss of Power 3 3
Failure to Power Up 3 3
Fumes or Vapors 3 3
Separation Failure 3 3
Sparking 3 3
Detachment of Device or Device Component 2 2
Visual Prompts will not Clear 2 2
Component Missing 2 2
Air Leak 2 2
Device Emits Odor 2 2
Device Reprocessing Problem 2 2
No Apparent Adverse Event 2 2
Failure to Shut Off 2 2
Device Damaged by Another Device 2 2
Difficult to Open or Close 2 2
Output Problem 2 2
Explosion 2 2
Physical Resistance/Sticking 2 2
Power Problem 2 2
Connection Problem 2 2
Malposition of Device 2 2
Dent in Material 2 2
Circuit Failure 2 2
Corroded 2 2
Material Discolored 1 1
Computer Software Problem 1 1
Device Alarm System 1 1
Occlusion Within Device 1 1
Unintended Collision 1 1
Failure to Reset 1 1
Failure to Fold 1 1
Device Maintenance Issue 1 1
Misfire 1 1
Delayed Charge Time 1 1
Electrical Shorting 1 1
Device Contamination with Body Fluid 1 1
Unstable 1 1
Positioning Problem 1 1
Improper Device Output 1 1
Mechanics Altered 1 1
Moisture or Humidity Problem 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
No Fail-Safe Mechanism 1 1
Difficult to Open or Remove Packaging Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Component Incompatible 1 1
Degraded 1 1
Disassembly 1 1
No Display/Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 567 567
No Known Impact Or Consequence To Patient 343 343
No Consequences Or Impact To Patient 250 250
No Clinical Signs, Symptoms or Conditions 115 115
Insufficient Information 19 19
No Information 14 14
No Code Available 4 4
Death 1 1
Blurred Vision 1 1
Injury 1 1
Chemical Exposure 1 1

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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