TPLC - Total Product Life Cycle

• Device: electrocautery, gynecologic (and accessories)
• Regulation Description: Gynecologic electrocautery 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
2015	27	27
2016	45	45
2017	23	23
2018	30	30
2019	127	127
2020	63	63

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	42	42
Device Operates Differently Than Expected	32	32
Failure to Cut	30	30
Therapeutic or Diagnostic Output Failure	20	20
Foot Pedal	15	15
Wire	15	15
Melted	13	13
Loss of Power	11	11
Sparking	11	11
Thermal Decomposition of Device	10	10
Defective Component	10	10
Adverse Event Without Identified Device or Use Problem	10	10
Power Problem	9	9
Device Stops Intermittently	9	9
Output Problem	9	9
Tip	8	8
Insufficient Information	8	8
Defective Device	8	8
Detachment of Device or Device Component	7	7
Foot Switch	7	7
Energy Output Problem	7	7
Device Displays Incorrect Message	7	7
Electrical /Electronic Property Problem	7	7
Inappropriate/Inadequate Shock/Stimulation	6	6
Material Fragmentation	6	6
Mechanical Problem	6	6
Electrode	5	5
Failure to Power Up	5	5
Overheating of Device	5	5
Noise, Audible	5	5
Temperature Problem	4	4
Activation Problem	4	4
Appropriate Term/Code Not Available	4	4
Cutter/Blade	4	4
Peeled/Delaminated	4	4
Device Inoperable	4	4
Intermittent Continuity	4	4
Material Integrity Problem	4	4
Mechanics Altered	3	3
Activation Failure	3	3
Loose or Intermittent Connection	3	3
Material Deformation	3	3
Arcing	3	3
Failure to Deliver Energy	3	3
No Display/Image	3	3
No Device Output	3	3
Nonstandard Device	3	3
Component Missing	3	3
Protective Measures Problem	3	3
Difficult to Open or Close	2	2
Intermittent Loss of Power	2	2
Unexpected Shutdown	2	2
Device Emits Odor	2	2
Smoking	2	2
Display or Visual Feedback Problem	2	2
Display	2	2
Insulation	2	2
Connection Problem	2	2
Electrical Shorting	2	2
Leak/Splash	2	2
Self-Activation or Keying	2	2
Jaw	2	2
Detachment Of Device Component	2	2
Output below Specifications	2	2
Complete Loss of Power	1	1
Switch, Push Button	1	1
Unintended Power Up	1	1
Material Discolored	1	1
Delivered as Unsterile Product	1	1
Grounding Malfunction	1	1
Circuit Failure	1	1
Diaphragm	1	1
Fuse	1	1
Housing	1	1
Screen	1	1
Power Conditioning Problem	1	1
Product Quality Problem	1	1
Electronic Property Issue	1	1
Flare or Flash	1	1
Improper Device Output	1	1
Compatibility Problem	1	1
Pad	1	1
Socket	1	1
Loss of or Failure to Bond	1	1
Use of Incorrect Control Settings	1	1
Degraded	1	1
Fire	1	1
Fracture	1	1
Electrical wires, defective	1	1
Device Slipped	1	1
Wire(s), breakage of	1	1
Structural Problem	1	1
Device Operational Issue	1	1
Failure to Shut Off	1	1
Cautery Tip	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	225	225
No Consequences Or Impact To Patient	24	24
No Information	20	20
Hemorrhage/Bleeding	10	10
Burn, Thermal	6	6
Blood Loss	5	5
No Patient Involvement	4	4
Foreign Body In Patient	4	4
Electric Shock	4	4
Burning Sensation	3	3
Pain	2	2
Injury	2	2
Burn(s)	2	2
Partial thickness (Second Degree) Burn	2	2
Vaginal Mucosa Damage	1	1
Failure to Anastomose	1	1
No Code Available	1	1
Radiation Exposure, Unintended	1	1
Alteration In Body Temperature	1	1
Shock	1	1
Tissue Damage	1	1
Laceration(s)	1	1
Tingling	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CooperSurgical, Inc.	II	Dec-05-2019
2	CooperSurgical, Inc.	II	Jul-23-2019
3	CooperSurgical, Inc.	II	Jun-19-2019
4	CooperSurgical, Inc.	II	May-15-2018