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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
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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