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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
2019 127 127
2020 102 102
2021 100 100
2022 104 104
2023 61 61
2024 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 57 57
Electrical /Electronic Property Problem 55 55
Break 53 53
Therapeutic or Diagnostic Output Failure 40 40
Failure to Cut 38 38
Mechanical Problem 33 33
Melted 22 22
Defective Component 22 22
Detachment of Device or Device Component 19 19
Nonstandard Device 19 19
Power Problem 17 17
Electrical Power Problem 14 14
Material Fragmentation 14 14
Energy Output Problem 14 14
Adverse Event Without Identified Device or Use Problem 13 13
Defective Device 12 12
Sparking 10 10
Thermal Decomposition of Device 10 10
Insufficient Information 10 10
Device Displays Incorrect Message 9 9
Overheating of Device 7 7
Peeled/Delaminated 7 7
Failure to Power Up 6 6
Leak/Splash 6 6
Loose or Intermittent Connection 6 6
Material Integrity Problem 6 6
Activation Problem 6 6
Appropriate Term/Code Not Available 5 5
Activation Failure 5 5
Noise, Audible 4 4
Output below Specifications 4 4
Display or Visual Feedback Problem 4 4
Smoking 4 4
Loss of Power 4 4
No Device Output 3 3
Delivered as Unsterile Product 3 3
Intermittent Continuity 3 3
Component Missing 3 3
Protective Measures Problem 3 3
Electrical Shorting 3 3
Unexpected Shutdown 3 3
Intermittent Energy Output 2 2
No Apparent Adverse Event 2 2
Patient Device Interaction Problem 2 2
Material Split, Cut or Torn 2 2
Intermittent Loss of Power 2 2
Flare or Flash 2 2
Compatibility Problem 2 2
Difficult to Open or Close 2 2
Arcing 2 2
Temperature Problem 2 2
Use of Device Problem 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Self-Activation or Keying 2 2
Circuit Failure 2 2
Failure to Deliver Energy 2 2
Fire 2 2
Loss of or Failure to Bond 2 2
Disconnection 2 2
Device Emits Odor 2 2
Grounding Malfunction 1 1
Decrease in Pressure 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
No Display/Image 1 1
Device Alarm System 1 1
Fracture 1 1
Computer Software Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Degraded 1 1
Material Discolored 1 1
Material Separation 1 1
Shipping Damage or Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Structural Problem 1 1
Dent in Material 1 1
Misfire 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Reset Problem 1 1
Mechanics Altered 1 1
Material Deformation 1 1
Unintended Electrical Shock 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 176 176
No Known Impact Or Consequence To Patient 153 153
Insufficient Information 103 103
Hemorrhage/Bleeding 22 22
No Consequences Or Impact To Patient 11 11
Burn(s) 9 9
No Information 9 9
Superficial (First Degree) Burn 9 9
Pain 5 5
Electric Shock 4 4
No Patient Involvement 4 4
Blood Loss 3 3
Unspecified Tissue Injury 3 3
Foreign Body In Patient 2 2
Burn, Thermal 2 2
Intermenstrual Bleeding 2 2
Distress 2 2
Laceration(s) 2 2
Abrasion 1 1
Tissue Damage 1 1
Burning Sensation 1 1
Tingling 1 1
Injury 1 1
Impaired Healing 1 1
Skin Tears 1 1
Alteration In Body Temperature 1 1
Partial thickness (Second Degree) Burn 1 1
Radiation Exposure, Unintended 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 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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