TPLC - Total Product Life Cycle

• 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