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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 1

MDR Year MDR Reports MDR Events
2015 27 27
2016 45 45
2017 23 23
2018 30 30
2019 127 127
2020 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Break 42 42
Device Operates Differently Than Expected 32 32
Failure to Cut 30 30
Therapeutic or Diagnostic Output Failure 20 20
Foot Pedal 15 15
Wire 15 15
Melted 13 13
Loss of Power 11 11
Sparking 11 11
Thermal Decomposition of Device 10 10
Defective Component 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Power Problem 9 9
Device Stops Intermittently 9 9
Output Problem 9 9
Tip 8 8
Insufficient Information 8 8
Defective Device 8 8
Detachment of Device or Device Component 7 7
Foot Switch 7 7
Energy Output Problem 7 7
Device Displays Incorrect Message 7 7
Electrical /Electronic Property Problem 7 7
Inappropriate/Inadequate Shock/Stimulation 6 6
Material Fragmentation 6 6
Mechanical Problem 6 6
Electrode 5 5
Failure to Power Up 5 5
Overheating of Device 5 5
Noise, Audible 5 5
Temperature Problem 4 4
Activation Problem 4 4
Appropriate Term/Code Not Available 4 4
Cutter/Blade 4 4
Peeled/Delaminated 4 4
Device Inoperable 4 4
Intermittent Continuity 4 4
Material Integrity Problem 4 4
Mechanics Altered 3 3
Activation Failure 3 3
Loose or Intermittent Connection 3 3
Material Deformation 3 3
Arcing 3 3
Failure to Deliver Energy 3 3
No Display/Image 3 3
No Device Output 3 3
Nonstandard Device 3 3
Component Missing 3 3
Protective Measures Problem 3 3
Difficult to Open or Close 2 2
Intermittent Loss of Power 2 2
Unexpected Shutdown 2 2
Device Emits Odor 2 2
Smoking 2 2
Display or Visual Feedback Problem 2 2
Display 2 2
Insulation 2 2
Connection Problem 2 2
Electrical Shorting 2 2
Leak/Splash 2 2
Self-Activation or Keying 2 2
Jaw 2 2
Detachment Of Device Component 2 2
Output below Specifications 2 2
Complete Loss of Power 1 1
Switch, Push Button 1 1
Unintended Power Up 1 1
Material Discolored 1 1
Delivered as Unsterile Product 1 1
Grounding Malfunction 1 1
Circuit Failure 1 1
Diaphragm 1 1
Fuse 1 1
Housing 1 1
Screen 1 1
Power Conditioning Problem 1 1
Product Quality Problem 1 1
Electronic Property Issue 1 1
Flare or Flash 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Pad 1 1
Socket 1 1
Loss of or Failure to Bond 1 1
Use of Incorrect Control Settings 1 1
Degraded 1 1
Fire 1 1
Fracture 1 1
Electrical wires, defective 1 1
Device Slipped 1 1
Wire(s), breakage of 1 1
Structural Problem 1 1
Device Operational Issue 1 1
Failure to Shut Off 1 1
Cautery Tip 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 225 225
No Consequences Or Impact To Patient 24 24
No Information 20 20
Hemorrhage/Bleeding 10 10
Burn, Thermal 6 6
Blood Loss 5 5
No Patient Involvement 4 4
Foreign Body In Patient 4 4
Electric Shock 4 4
Burning Sensation 3 3
Pain 2 2
Injury 2 2
Burn(s) 2 2
Partial thickness (Second Degree) Burn 2 2
Vaginal Mucosa Damage 1 1
Failure to Anastomose 1 1
No Code Available 1 1
Radiation Exposure, Unintended 1 1
Alteration In Body Temperature 1 1
Shock 1 1
Tissue Damage 1 1
Laceration(s) 1 1
Tingling 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II Dec-05-2019
2 CooperSurgical, Inc. II Jul-23-2019
3 CooperSurgical, Inc. II Jun-19-2019
4 CooperSurgical, Inc. II May-15-2018
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