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
2019	127	127
2020	102	102
2021	100	100
2022	104	104
2023	61	61
2024	15	15

Device Problems	MDRs with this Device Problem	Events in those MDRs
Output Problem	57	57
Break	50	50
Electrical /Electronic Property Problem	50	50
Therapeutic or Diagnostic Output Failure	40	40
Failure to Cut	38	38
Mechanical Problem	33	33
Defective Component	22	22
Melted	21	21
Nonstandard Device	19	19
Detachment of Device or Device Component	19	19
Power Problem	17	17
Energy Output Problem	14	14
Electrical Power Problem	14	14
Material Fragmentation	14	14
Adverse Event Without Identified Device or Use Problem	13	13
Defective Device	12	12
Insufficient Information	10	10
Thermal Decomposition of Device	10	10
Sparking	10	10
Device Displays Incorrect Message	9	9
Overheating of Device	7	7
Loose or Intermittent Connection	6	6
Failure to Power Up	6	6
Leak/Splash	6	6
Peeled/Delaminated	6	6
Activation Problem	6	6
Material Integrity Problem	6	6
Appropriate Term/Code Not Available	5	5
Activation Failure	5	5
Output below Specifications	4	4
Smoking	4	4
Loss of Power	4	4
Noise, Audible	4	4
Display or Visual Feedback Problem	4	4
No Device Output	3	3
Unexpected Shutdown	3	3
Protective Measures Problem	3	3
Electrical Shorting	3	3
Component Missing	3	3
Delivered as Unsterile Product	3	3
Intermittent Continuity	3	3
Self-Activation or Keying	2	2
Use of Device Problem	2	2
Difficult to Open or Close	2	2
No Apparent Adverse Event	2	2
Intermittent Energy Output	2	2
Material Split, Cut or Torn	2	2
Loss of or Failure to Bond	2	2
Compatibility Problem	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Flare or Flash	2	2
Fire	2	2
Arcing	2	2
Patient Device Interaction Problem	2	2
Intermittent Loss of Power	2	2
Device Emits Odor	2	2
Failure to Deliver Energy	2	2
Temperature Problem	2	2
Disconnection	2	2
Grounding Malfunction	1	1
Mechanics Altered	1	1
Computer Software Problem	1	1
Device Alarm System	1	1
Device Damaged Prior to Use	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Use of Incorrect Control/Treatment Settings	1	1
Material Separation	1	1
Dent in Material	1	1
Reset Problem	1	1
Decrease in Pressure	1	1
Physical Resistance/Sticking	1	1
Material Deformation	1	1
Unintended Movement	1	1
Excessive Heating	1	1
Fracture	1	1
Unintended Electrical Shock	1	1
Material Discolored	1	1
Improper or Incorrect Procedure or Method	1	1
Product Quality Problem	1	1
No Display/Image	1	1
Structural Problem	1	1
Material Puncture/Hole	1	1
Shipping Damage or Problem	1	1
Degraded	1	1
Misfire	1	1
Connection Problem	1	1
Contamination /Decontamination Problem	1	1
Circuit Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	167	167
No Known Impact Or Consequence To Patient	153	153
Insufficient Information	101	101
Hemorrhage/Bleeding	22	22
No Consequences Or Impact To Patient	11	11
Burn(s)	9	9
No Information	9	9
Superficial (First Degree) Burn	9	9
Pain	4	4
Electric Shock	4	4
No Patient Involvement	4	4
Blood Loss	3	3
Unspecified Tissue Injury	3	3
Foreign Body In Patient	2	2
Burn, Thermal	2	2
Intermenstrual Bleeding	2	2
Distress	2	2
Laceration(s)	2	2
Abrasion	1	1
Tissue Damage	1	1
Burning Sensation	1	1
Tingling	1	1
Injury	1	1
Impaired Healing	1	1
Skin Tears	1	1
Alteration In Body Temperature	1	1
Partial thickness (Second Degree) Burn	1	1
Radiation Exposure, Unintended	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	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022