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TPLC
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Device
electrocautery, gynecologic (and accessories)
Regulation Description
Gynecologic electrocautery and accessories.
Product Code
HGI
Regulation Number
884.4120
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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