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	12	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
Output Problem	57	57
Break	49	49
Electrical /Electronic Property Problem	49	49
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
Electrical Power Problem	14	14
Material Fragmentation	14	14
Energy Output Problem	14	14
Adverse Event Without Identified Device or Use Problem	13	13
Defective Device	12	12
Sparking	10	10
Thermal Decomposition of Device	10	10
Insufficient Information	10	10
Device Displays Incorrect Message	9	9
Overheating of Device	7	7
Peeled/Delaminated	6	6
Failure to Power Up	6	6
Leak/Splash	6	6
Loose or Intermittent Connection	6	6
Material Integrity Problem	6	6
Activation Problem	6	6
Appropriate Term/Code Not Available	5	5
Activation Failure	5	5
Noise, Audible	4	4
Output below Specifications	4	4
Display or Visual Feedback Problem	4	4
Smoking	4	4
Loss of Power	4	4
No Device Output	3	3
Delivered as Unsterile Product	3	3
Intermittent Continuity	3	3
Component Missing	3	3
Protective Measures Problem	3	3
Electrical Shorting	3	3
Unexpected Shutdown	3	3
Intermittent Energy Output	2	2
No Apparent Adverse Event	2	2
Patient Device Interaction Problem	2	2
Material Split, Cut or Torn	2	2
Intermittent Loss of Power	2	2
Flare or Flash	2	2
Compatibility Problem	2	2
Difficult to Open or Close	2	2
Arcing	2	2
Temperature Problem	2	2
Use of Device Problem	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Self-Activation or Keying	2	2
Failure to Deliver Energy	2	2
Fire	2	2
Loss of or Failure to Bond	2	2
Disconnection	2	2
Device Emits Odor	2	2
Grounding Malfunction	1	1
Decrease in Pressure	1	1
Material Puncture/Hole	1	1
Product Quality Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
No Display/Image	1	1
Device Alarm System	1	1
Fracture	1	1
Use of Incorrect Control/Treatment Settings	1	1
Degraded	1	1
Material Discolored	1	1
Circuit Failure	1	1
Computer Software Problem	1	1
Material Separation	1	1
Shipping Damage or Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Device Damaged Prior to Use	1	1
Structural Problem	1	1
Dent in Material	1	1
Misfire	1	1
Contamination /Decontamination Problem	1	1
Connection Problem	1	1
Reset Problem	1	1
Mechanics Altered	1	1
Material Deformation	1	1
Unintended Electrical Shock	1	1
Unintended Movement	1	1
Physical Resistance/Sticking	1	1
Excessive Heating	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	165	165
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	8	8
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