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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
Mechanical Problem 29 29
Therapeutic or Diagnostic Output Failure 29 29
Failure to Cut 23 23
Nonstandard Device 17 17
Melted 16 16
Defective Component 15 15
Detachment of Device or Device 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
Overheating of Device 7 7
Defective Device 7 7
Sparking 6 6
Device Displays Incorrect Message 6 6
Peeled/Delaminated 6 6
Leak/Splash 5 5
Material Integrity Problem 5 5
Failure to Power Up 5 5
Output below Specifications 4 4
Loose or Intermittent Connection 4 4
Activation Problem 4 4
Smoking 4 4
Thermal Decomposition of Device 4 4
Noise, Audible 3 3
Loss of Power 3 3
Component Missing 3 3
No Device Output 2 2
Loss of or Failure to Bond 2 2
Display or Visual Feedback Problem 2 2
Appropriate Term/Code Not Available 2 2
Activation Failure 2 2
No Apparent Adverse Event 2 2
Delivered as Unsterile Product 2 2
Flare or Flash 2 2
Circuit Failure 2 2
Use of Device Problem 2 2
Disconnection 2 2
Compatibility Problem 2 2
Material Split, Cut or Torn 2 2
Unexpected Shutdown 2 2
Patient Device Interaction Problem 2 2
Fire 2 2
Intermittent Energy Output 2 2
Temperature Problem 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
Superficial (First Degree) Burn 9 9
Burn(s) 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
Blood Loss 2 2
Intermenstrual Bleeding 2 2
No Patient Involvement 2 2
Laceration(s) 2 2
Distress 2 2
Impaired Healing 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Information 1 1
Abrasion 1 1
Burn, Thermal 1 1
Skin Tears 1 1
Partial thickness (Second Degree) Burn 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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