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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)
Regulation Description Gynecologic electrocautery and accessories.
Product CodeHGI
Regulation Number 884.4120
Device Class 2


Premarket Reviews
ManufacturerDecision
LIGER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 56 56
2017 33 33
2018 30 30
2019 127 127
2020 102 102
2021 87 87

Device Problems MDRs with this Device Problem Events in those MDRs
Break 57 57
Failure to Cut 44 44
Therapeutic or Diagnostic Output Failure 38 38
Output Problem 27 27
Device Operates Differently Than Expected 19 19
Melted 19 19
Defective Component 16 16
Power Problem 15 15
Sparking 15 15
Adverse Event Without Identified Device or Use Problem 13 13
Defective Device 12 12
Thermal Decomposition of Device 12 12
Material Fragmentation 11 11
Energy Output Problem 11 11
Loss of Power 11 11
Device Displays Incorrect Message 10 10
Mechanical Problem 10 10
Detachment of Device or Device Component 10 10
Insufficient Information 10 10
Material Integrity Problem 9 9
Failure to Power Up 7 7
Overheating of Device 7 7
Electrical /Electronic Property Problem 6 6
Inappropriate/Inadequate Shock/Stimulation 6 6
Device Stops Intermittently 6 6
Activation Failure 6 6
Noise, Audible 6 6
Temperature Problem 5 5
Appropriate Term/Code Not Available 5 5
Peeled/Delaminated 5 5
Loose or Intermittent Connection 5 5
Leak/Splash 4 4
No Device Output 4 4
Intermittent Continuity 4 4
Device Inoperable 4 4
Component Missing 4 4
Mechanics Altered 4 4
Connection Problem 4 4
Activation Problem 4 4
Material Deformation 3 3
Output below Specifications 3 3
Protective Measures Problem 3 3
Arcing 3 3
Smoking 3 3
Self-Activation or Keying 3 3
Fire 3 3
Display or Visual Feedback Problem 3 3
Nonstandard Device 3 3
Delivered as Unsterile Product 3 3
Device Emits Odor 2 2
No Display/Image 2 2
Failure to Deliver Energy 2 2
Use of Incorrect Control Settings 2 2
Circuit Failure 2 2
Detachment Of Device Component 2 2
Improper or Incorrect Procedure or Method 2 2
Difficult to Open or Close 2 2
Electrical Shorting 2 2
Material Split, Cut or Torn 2 2
Intermittent Loss of Power 2 2
Unexpected Shutdown 2 2
Intermittent Energy Output 1 1
Complete Loss of Power 1 1
Electronic Property Issue 1 1
Failure to Shut Off 1 1
Flare or Flash 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Contamination /Decontamination Problem 1 1
Reset Problem 1 1
Device Operational Issue 1 1
Device Damaged Prior to Use 1 1
Use of Device Problem 1 1
Material Separation 1 1
Structural Problem 1 1
Dent in Material 1 1
Computer Software Problem 1 1
Degraded 1 1
Unintended Power Up 1 1
Material Discolored 1 1
Fracture 1 1
Device Alarm System 1 1
Loss of or Failure to Bond 1 1
Grounding Malfunction 1 1
Power Conditioning Problem 1 1
Decrease in Pressure 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 205 205
Insufficient Information 73 73
No Clinical Signs, Symptoms or Conditions 57 57
No Consequences Or Impact To Patient 22 22
No Information 20 20
Hemorrhage/Bleeding 15 15
Burn, Thermal 6 6
Electric Shock 5 5
Blood Loss 5 5
Burn(s) 5 5
Pain 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 2 2
Partial thickness (Second Degree) Burn 2 2
Radiation Exposure, Unintended 1 1
No Code Available 1 1
Impaired Healing 1 1
Discomfort 1 1
Alteration In Body Temperature 1 1
Superficial (First Degree) Burn 1 1
Tingling 1 1
Tissue Damage 1 1
Failure to Anastomose 1 1
Laceration(s) 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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