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TPLC
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Device
electrocautery, gynecologic (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
2018
30
30
2019
127
127
2020
102
102
2021
100
100
2022
104
104
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
56
56
Output Problem
52
52
Therapeutic or Diagnostic Output Failure
39
39
Failure to Cut
39
39
Defective Component
21
21
Nonstandard Device
19
19
Melted
18
18
Detachment of Device or Device Component
17
17
Power Problem
17
17
Material Fragmentation
15
15
Mechanical Problem
15
15
Adverse Event Without Identified Device or Use Problem
15
15
Energy Output Problem
14
14
Sparking
13
13
Electrical /Electronic Property Problem
12
12
Defective Device
12
12
Thermal Decomposition of Device
10
10
Device Displays Incorrect Message
10
10
Insufficient Information
9
9
Activation Problem
7
7
Overheating of Device
7
7
Electrical Power Problem
7
7
Loss of Power
7
7
Material Integrity Problem
7
7
Peeled/Delaminated
6
6
Leak/Splash
6
6
Failure to Power Up
6
6
Loose or Intermittent Connection
6
6
Activation Failure
5
5
Appropriate Term/Code Not Available
5
5
Noise, Audible
5
5
Smoking
4
4
Display or Visual Feedback Problem
4
4
Output below Specifications
4
4
Intermittent Continuity
4
4
Delivered as Unsterile Product
3
3
Self-Activation or Keying
3
3
No Device Output
3
3
Component Missing
3
3
Protective Measures Problem
3
3
Unexpected Shutdown
3
3
Inappropriate/Inadequate Shock/Stimulation
3
3
Electrical Shorting
3
3
Compatibility Problem
2
2
Device Inoperable
2
2
Product Quality Problem
2
2
Arcing
2
2
Intermittent Loss of Power
2
2
Device Emits Odor
2
2
Failure to Deliver Energy
2
2
Fire
2
2
Fracture
2
2
Loss of or Failure to Bond
2
2
Material Split, Cut or Torn
2
2
Intermittent Energy Output
2
2
Difficult to Open or Close
2
2
Temperature Problem
2
2
No Apparent Adverse Event
2
2
Mechanics Altered
2
2
Circuit Failure
2
2
Disconnection
2
2
Connection Problem
2
2
Complete Loss of Power
1
1
Device Alarm System
1
1
Grounding Malfunction
1
1
Computer Software Problem
1
1
Unintended Power Up
1
1
Contamination /Decontamination Problem
1
1
Device Damaged Prior to Use
1
1
Misfire
1
1
Degraded
1
1
No Display/Image
1
1
Structural Problem
1
1
Use of Device Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Shipping Damage or Problem
1
1
Material Separation
1
1
Device Operates Differently Than Expected
1
1
Use of Incorrect Control/Treatment Settings
1
1
Reset Problem
1
1
Unintended Movement
1
1
Physical Resistance/Sticking
1
1
Device Stops Intermittently
1
1
Decrease in Pressure
1
1
Detachment Of Device Component
1
1
Material Discolored
1
1
Improper or Incorrect Procedure or Method
1
1
Dent in Material
1
1
Material Deformation
1
1
Electronic Property Issue
1
1
Flare or Flash
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
166
166
No Clinical Signs, Symptoms or Conditions
103
103
Insufficient Information
101
101
Hemorrhage/Bleeding
20
20
No Consequences Or Impact To Patient
15
15
No Information
14
14
Superficial (First Degree) Burn
8
8
Burn(s)
7
7
Pain
5
5
Burn, Thermal
5
5
Blood Loss
4
4
No Patient Involvement
4
4
Electric Shock
4
4
Foreign Body In Patient
3
3
Intermenstrual Bleeding
2
2
Burning Sensation
2
2
Distress
2
2
Injury
1
1
Impaired Healing
1
1
Alteration In Body Temperature
1
1
Radiation Exposure, Unintended
1
1
Laceration(s)
1
1
Shock
1
1
Tissue Damage
1
1
Tingling
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Failure to Anastomose
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
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
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