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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
2017
33
33
2018
30
30
2019
127
127
2020
102
102
2021
100
100
2022
69
69
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
57
57
Output Problem
53
53
Failure to Cut
40
40
Therapeutic or Diagnostic Output Failure
38
38
Defective Component
20
20
Melted
20
20
Nonstandard Device
19
19
Power Problem
18
18
Adverse Event Without Identified Device or Use Problem
16
16
Sparking
14
14
Energy Output Problem
14
14
Material Fragmentation
12
12
Defective Device
12
12
Device Displays Incorrect Message
11
11
Detachment of Device or Device Component
10
10
Thermal Decomposition of Device
10
10
Mechanical Problem
9
9
Material Integrity Problem
9
9
Insufficient Information
9
9
Loss of Power
8
8
Electrical /Electronic Property Problem
8
8
Overheating of Device
7
7
Peeled/Delaminated
7
7
Activation Problem
7
7
Noise, Audible
6
6
Failure to Power Up
6
6
Leak/Splash
6
6
Loose or Intermittent Connection
6
6
Inappropriate/Inadequate Shock/Stimulation
6
6
Appropriate Term/Code Not Available
5
5
Activation Failure
5
5
Output below Specifications
4
4
Smoking
4
4
Component Missing
4
4
Device Operates Differently Than Expected
4
4
Display or Visual Feedback Problem
4
4
No Device Output
4
4
Intermittent Continuity
4
4
Fire
3
3
Delivered as Unsterile Product
3
3
Electrical Shorting
3
3
Connection Problem
3
3
Material Deformation
3
3
Protective Measures Problem
3
3
Self-Activation or Keying
3
3
Unexpected Shutdown
3
3
Intermittent Energy Output
3
3
Material Split, Cut or Torn
2
2
Intermittent Loss of Power
2
2
Temperature Problem
2
2
No Apparent Adverse Event
2
2
Product Quality Problem
2
2
Device Inoperable
2
2
Improper or Incorrect Procedure or Method
2
2
Compatibility Problem
2
2
Mechanics Altered
2
2
Arcing
2
2
Difficult to Open or Close
2
2
Device Emits Odor
2
2
Fracture
2
2
Failure to Deliver Energy
2
2
Loss of or Failure to Bond
2
2
Disconnection
2
2
Circuit Failure
2
2
Detachment Of Device Component
1
1
Computer Software Problem
1
1
Use of Incorrect Control Settings
1
1
Degraded
1
1
Unintended Power Up
1
1
Material Discolored
1
1
No Display/Image
1
1
Device Alarm System
1
1
Grounding Malfunction
1
1
Decrease in Pressure
1
1
Electronic Property Issue
1
1
Flare or Flash
1
1
Contamination /Decontamination Problem
1
1
Reset Problem
1
1
Device Damaged Prior to Use
1
1
Structural Problem
1
1
Dent in Material
1
1
Misfire
1
1
Use of Device Problem
1
1
Device Stops Intermittently
1
1
Incorrect, Inadequate or Imprecise Resultor Readings
1
1
Material Separation
1
1
Shipping Damage or Problem
1
1
Unintended Movement
1
1
Complete Loss of Power
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
175
175
Insufficient Information
103
103
No Clinical Signs, Symptoms or Conditions
82
82
Hemorrhage/Bleeding
19
19
No Consequences Or Impact To Patient
18
18
No Information
16
16
Superficial (First Degree) Burn
7
7
Burn, Thermal
6
6
Burn(s)
6
6
Pain
5
5
Electric Shock
5
5
Blood Loss
5
5
No Patient Involvement
4
4
Foreign Body In Patient
4
4
Burning Sensation
3
3
Intermenstrual Bleeding
2
2
Distress
2
2
Injury
1
1
Impaired Healing
1
1
Alteration In Body Temperature
1
1
Tingling
1
1
Tissue Damage
1
1
Failure to Anastomose
1
1
Laceration(s)
1
1
Partial thickness (Second Degree) Burn
1
1
Radiation Exposure, Unintended
1
1
No Code Available
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
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
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