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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrocautery, gynecologic (and accessories)
Product CodeHGI
Regulation Number 884.4120
Device Class 2


Premarket Reviews
ManufacturerDecision
LIGER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 30 30
2019 127 127
2020 102 102
2021 100 100
2022 104 104

Device Problems MDRs with this Device Problem Events in those MDRs
Break 56 56
Output Problem 52 52
Therapeutic or Diagnostic Output Failure 39 39
Failure to Cut 39 39
Defective Component 21 21
Nonstandard Device 19 19
Melted 18 18
Detachment of Device or Device Component 17 17
Power Problem 17 17
Material Fragmentation 15 15
Mechanical Problem 15 15
Adverse Event Without Identified Device or Use Problem 15 15
Energy Output Problem 14 14
Sparking 13 13
Electrical /Electronic Property Problem 12 12
Defective Device 12 12
Thermal Decomposition of Device 10 10
Device Displays Incorrect Message 10 10
Insufficient Information 9 9
Activation Problem 7 7
Overheating of Device 7 7
Electrical Power Problem 7 7
Loss of Power 7 7
Material Integrity Problem 7 7
Peeled/Delaminated 6 6
Leak/Splash 6 6
Failure to Power Up 6 6
Loose or Intermittent Connection 6 6
Activation Failure 5 5
Appropriate Term/Code Not Available 5 5
Noise, Audible 5 5
Smoking 4 4
Display or Visual Feedback Problem 4 4
Output below Specifications 4 4
Intermittent Continuity 4 4
Delivered as Unsterile Product 3 3
Self-Activation or Keying 3 3
No Device Output 3 3
Component Missing 3 3
Protective Measures Problem 3 3
Unexpected Shutdown 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Electrical Shorting 3 3
Compatibility Problem 2 2
Device Inoperable 2 2
Product Quality Problem 2 2
Arcing 2 2
Intermittent Loss of Power 2 2
Device Emits Odor 2 2
Failure to Deliver Energy 2 2
Fire 2 2
Fracture 2 2
Loss of or Failure to Bond 2 2
Material Split, Cut or Torn 2 2
Intermittent Energy Output 2 2
Difficult to Open or Close 2 2
Temperature Problem 2 2
No Apparent Adverse Event 2 2
Mechanics Altered 2 2
Circuit Failure 2 2
Disconnection 2 2
Connection Problem 2 2
Complete Loss of Power 1 1
Device Alarm System 1 1
Grounding Malfunction 1 1
Computer Software Problem 1 1
Unintended Power Up 1 1
Contamination /Decontamination Problem 1 1
Device Damaged Prior to Use 1 1
Misfire 1 1
Degraded 1 1
No Display/Image 1 1
Structural Problem 1 1
Use of Device Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Shipping Damage or Problem 1 1
Material Separation 1 1
Device Operates Differently Than Expected 1 1
Use of Incorrect Control/Treatment Settings 1 1
Reset Problem 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1
Device Stops Intermittently 1 1
Decrease in Pressure 1 1
Detachment Of Device Component 1 1
Material Discolored 1 1
Improper or Incorrect Procedure or Method 1 1
Dent in Material 1 1
Material Deformation 1 1
Electronic Property Issue 1 1
Flare or Flash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 166 166
No Clinical Signs, Symptoms or Conditions 103 103
Insufficient Information 101 101
Hemorrhage/Bleeding 20 20
No Consequences Or Impact To Patient 15 15
No Information 14 14
Superficial (First Degree) Burn 8 8
Burn(s) 7 7
Pain 5 5
Burn, Thermal 5 5
Blood Loss 4 4
No Patient Involvement 4 4
Electric Shock 4 4
Foreign Body In Patient 3 3
Intermenstrual Bleeding 2 2
Burning Sensation 2 2
Distress 2 2
Injury 1 1
Impaired Healing 1 1
Alteration In Body Temperature 1 1
Radiation Exposure, Unintended 1 1
Laceration(s) 1 1
Shock 1 1
Tissue Damage 1 1
Tingling 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Failure to Anastomose 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II Nov-18-2021
2 CooperSurgical, Inc. II Dec-05-2019
3 CooperSurgical, Inc. II Jul-23-2019
4 CooperSurgical, Inc. II Jun-19-2019
5 CooperSurgical, Inc. II May-15-2018
6 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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