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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)
Product CodeHGI
Regulation Number 884.4120
Device Class 2


Premarket Reviews
ManufacturerDecision
DOMAIN SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
LIGER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1 1
2015 27 27
2016 56 56
2017 33 33
2018 30 30
2019 127 127
2020 102 102
2021 100 100
2022 104 104
2023 61 61
2024 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Break 71 71
Electrical /Electronic Property Problem 65 65
Output Problem 64 64
Failure to Cut 50 50
Therapeutic or Diagnostic Output Failure 45 45
Mechanical Problem 36 36
Device Operates Differently Than Expected 32 32
Melted 27 27
Defective Component 22 22
Nonstandard Device 19 19
Detachment of Device or Device Component 19 19
Power Problem 18 18
Sparking 18 18
Adverse Event Without Identified Device or Use Problem 17 17
Material Fragmentation 17 17
Energy Output Problem 15 15
Electrical Power Problem 14 14
Insufficient Information 14 14
Defective Device 13 13
Loss of Power 12 12
Device Displays Incorrect Message 12 12
Thermal Decomposition of Device 12 12
Peeled/Delaminated 9 9
Material Integrity Problem 9 9
Overheating of Device 9 9
Device Stops Intermittently 9 9
Noise, Audible 7 7
Failure to Power Up 7 7
Activation Failure 7 7
Activation Problem 7 7
Inappropriate/Inadequate Shock/Stimulation 7 7
Output below Specifications 6 6
Leak/Splash 6 6
Loose or Intermittent Connection 6 6
Component Missing 5 5
Appropriate Term/Code Not Available 5 5
Temperature Problem 5 5
Smoking 4 4
Device Inoperable 4 4
No Device Output 4 4
Mechanics Altered 4 4
Intermittent Continuity 4 4
Display or Visual Feedback Problem 4 4
Connection Problem 4 4
Arcing 4 4
Self-Activation or Keying 3 3
Protective Measures Problem 3 3
Electrical Shorting 3 3
No Display/Image 3 3
Fire 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 226 226
No Clinical Signs, Symptoms or Conditions 191 191
Insufficient Information 115 115
Hemorrhage/Bleeding 30 30
No Consequences Or Impact To Patient 24 24
No Information 20 20
Burn(s) 11 11
Superficial (First Degree) Burn 9 9
Pain 9 9
Electric Shock 7 7
Burn, Thermal 6 6
Blood Loss 5 5
Foreign Body In Patient 5 5
No Patient Involvement 4 4
Intermenstrual Bleeding 3 3
Burning Sensation 3 3
Laceration(s) 3 3
Unspecified Tissue Injury 3 3
Partial thickness (Second Degree) Burn 3 3
Injury 2 2
Shock 2 2
Distress 2 2
Impaired Healing 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Tingling 1 1
Radiation Exposure, Unintended 1 1
No Code Available 1 1
Abrasion 1 1
Vaginal Mucosa Damage 1 1
Alteration In Body Temperature 1 1
Cramp(s) 1 1
Discomfort 1 1
Failure to Anastomose 1 1
Tissue Damage 1 1
Skin Tears 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
6 CooperSurgical, Inc. II Dec-02-2014
7 Gynex Corporation III Oct-03-2012
8 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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