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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
2020 102 102
2021 100 100
2022 104 104
2023 61 61
2024 44 44
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 65 65
Output Problem 49 49
Break 36 36
Mechanical Problem 29 29
Therapeutic or Diagnostic Output Failure 28 28
Failure to Cut 23 23
Nonstandard Device 17 17
Melted 16 16
Defective Component 15 15
Detachment of Device or Device Component 15 15
Power Problem 14 14
Electrical Power Problem 14 14
Material Fragmentation 12 12
Energy Output Problem 11 11
Insufficient Information 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Overheating of Device 7 7
Defective Device 7 7
Sparking 6 6
Device Displays Incorrect Message 6 6
Peeled/Delaminated 6 6
Failure to Power Up 5 5
Leak/Splash 5 5
Material Integrity Problem 5 5
Activation Problem 4 4
Thermal Decomposition of Device 4 4
Smoking 4 4
Output below Specifications 4 4
Loose or Intermittent Connection 4 4
Component Missing 3 3
Noise, Audible 3 3
Patient Device Interaction Problem 2 2
Activation Failure 2 2
Compatibility Problem 2 2
Use of Device Problem 2 2
Fire 2 2
Disconnection 2 2
Flare or Flash 2 2
No Device Output 2 2
Unexpected Shutdown 2 2
Circuit Failure 2 2
Loss of Power 2 2
No Apparent Adverse Event 2 2
Delivered as Unsterile Product 2 2
Intermittent Energy Output 2 2
Material Split, Cut or Torn 2 2
Loss of or Failure to Bond 2 2
Display or Visual Feedback Problem 2 2
Appropriate Term/Code Not Available 2 2
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 190 190
Insufficient Information 104 104
No Known Impact Or Consequence To Patient 52 52
Hemorrhage/Bleeding 22 22
Burn(s) 9 9
Superficial (First Degree) Burn 9 9
Pain 6 6
No Consequences Or Impact To Patient 4 4
Foreign Body In Patient 4 4
Electric Shock 3 3
Unspecified Tissue Injury 3 3
Distress 2 2
Laceration(s) 2 2
Blood Loss 2 2
No Patient Involvement 2 2
Intermenstrual Bleeding 2 2
Impaired Healing 1 1
Skin Tears 1 1
Burn, Thermal 1 1
Abrasion 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Partial thickness (Second Degree) Burn 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II Nov-18-2021
2 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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