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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
2017 33 33
2018 30 30
2019 127 127
2020 102 102
2021 100 100
2022 69 69

Device Problems MDRs with this Device Problem Events in those MDRs
Break 57 57
Output Problem 53 53
Failure to Cut 40 40
Therapeutic or Diagnostic Output Failure 38 38
Defective Component 20 20
Melted 20 20
Nonstandard Device 19 19
Power Problem 18 18
Adverse Event Without Identified Device or Use Problem 16 16
Sparking 14 14
Energy Output Problem 14 14
Material Fragmentation 12 12
Defective Device 12 12
Device Displays Incorrect Message 11 11
Detachment of Device or Device Component 10 10
Thermal Decomposition of Device 10 10
Mechanical Problem 9 9
Material Integrity Problem 9 9
Insufficient Information 9 9
Loss of Power 8 8
Electrical /Electronic Property Problem 8 8
Overheating of Device 7 7
Peeled/Delaminated 7 7
Activation Problem 7 7
Noise, Audible 6 6
Failure to Power Up 6 6
Leak/Splash 6 6
Loose or Intermittent Connection 6 6
Inappropriate/Inadequate Shock/Stimulation 6 6
Appropriate Term/Code Not Available 5 5
Activation Failure 5 5
Output below Specifications 4 4
Smoking 4 4
Component Missing 4 4
Device Operates Differently Than Expected 4 4
Display or Visual Feedback Problem 4 4
No Device Output 4 4
Intermittent Continuity 4 4
Fire 3 3
Delivered as Unsterile Product 3 3
Electrical Shorting 3 3
Connection Problem 3 3
Material Deformation 3 3
Protective Measures Problem 3 3
Self-Activation or Keying 3 3
Unexpected Shutdown 3 3
Intermittent Energy Output 3 3
Material Split, Cut or Torn 2 2
Intermittent Loss of Power 2 2
Temperature Problem 2 2
No Apparent Adverse Event 2 2
Product Quality Problem 2 2
Device Inoperable 2 2
Improper or Incorrect Procedure or Method 2 2
Compatibility Problem 2 2
Mechanics Altered 2 2
Arcing 2 2
Difficult to Open or Close 2 2
Device Emits Odor 2 2
Fracture 2 2
Failure to Deliver Energy 2 2
Loss of or Failure to Bond 2 2
Disconnection 2 2
Circuit Failure 2 2
Detachment Of Device Component 1 1
Computer Software Problem 1 1
Use of Incorrect Control Settings 1 1
Degraded 1 1
Unintended Power Up 1 1
Material Discolored 1 1
No Display/Image 1 1
Device Alarm System 1 1
Grounding Malfunction 1 1
Decrease in Pressure 1 1
Electronic Property Issue 1 1
Flare or Flash 1 1
Contamination /Decontamination Problem 1 1
Reset Problem 1 1
Device Damaged Prior to Use 1 1
Structural Problem 1 1
Dent in Material 1 1
Misfire 1 1
Use of Device Problem 1 1
Device Stops Intermittently 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Material Separation 1 1
Shipping Damage or Problem 1 1
Unintended Movement 1 1
Complete Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 175 175
Insufficient Information 103 103
No Clinical Signs, Symptoms or Conditions 82 82
Hemorrhage/Bleeding 19 19
No Consequences Or Impact To Patient 18 18
No Information 16 16
Superficial (First Degree) Burn 7 7
Burn, Thermal 6 6
Burn(s) 6 6
Pain 5 5
Electric Shock 5 5
Blood Loss 5 5
No Patient Involvement 4 4
Foreign Body In Patient 4 4
Burning Sensation 3 3
Intermenstrual Bleeding 2 2
Distress 2 2
Injury 1 1
Impaired Healing 1 1
Alteration In Body Temperature 1 1
Tingling 1 1
Tissue Damage 1 1
Failure to Anastomose 1 1
Laceration(s) 1 1
Partial thickness (Second Degree) Burn 1 1
Radiation Exposure, Unintended 1 1
No Code Available 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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
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