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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 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 74 74
Output Problem 49 49
Break 38 38
Therapeutic or Diagnostic Output Failure 29 29
Mechanical Problem 29 29
Failure to Cut 23 23
Nonstandard Device 17 17
Melted 16 16
Detachment of Device or Device Component 15 15
Defective Component 15 15
Electrical Power Problem 14 14
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
Defective Device 7 7
Overheating of Device 7 7
Peeled/Delaminated 6 6
Device Displays Incorrect Message 6 6
Sparking 6 6
Leak/Splash 5 5
Failure to Power Up 5 5
Material Integrity Problem 5 5
Loose or Intermittent Connection 4 4
Thermal Decomposition of Device 4 4
Output below Specifications 4 4
Smoking 4 4
Activation Problem 4 4
Loss of Power 3 3
Component Missing 3 3
Noise, Audible 3 3
Fire 2 2
Display or Visual Feedback Problem 2 2
Disconnection 2 2
Circuit Failure 2 2
Loss of or Failure to Bond 2 2
Intermittent Energy Output 2 2
Unexpected Shutdown 2 2
Flare or Flash 2 2
Material Split, Cut or Torn 2 2
Patient Device Interaction Problem 2 2
Compatibility Problem 2 2
Activation Failure 2 2
Appropriate Term/Code Not Available 2 2
No Apparent Adverse Event 2 2
No Device Output 2 2
Delivered as Unsterile Product 2 2
Use of Device Problem 2 2
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 202 202
Insufficient Information 106 106
No Known Impact Or Consequence To Patient 52 52
Hemorrhage/Bleeding 23 23
Burn(s) 9 9
Superficial (First Degree) Burn 9 9
Pain 6 6
Foreign Body In Patient 4 4
No Consequences Or Impact To Patient 4 4
Electric Shock 3 3
Unspecified Tissue Injury 3 3
Distress 2 2
Blood Loss 2 2
No Patient Involvement 2 2
Intermenstrual Bleeding 2 2
Laceration(s) 2 2
Impaired Healing 1 1
Skin Tears 1 1
Burn, Thermal 1 1
Abrasion 1 1
Partial thickness (Second Degree) Burn 1 1
No Information 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 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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