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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
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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