TPLC - Total Product Life Cycle

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Device	electrocautery, gynecologic (and accessories)
Regulation Description	Gynecologic electrocautery and accessories.
Product Code	HGI
Regulation Number	884.4120
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Electrical /Electronic Property Problem	74	74
Output Problem	49	49
Break	38	38
Mechanical Problem	29	29
Therapeutic or Diagnostic Output Failure	29	29
Failure to Cut	23	23
Nonstandard Device	17	17
Melted	16	16
Defective Component	15	15
Detachment of Device or Device Component	15	15
Electrical Power Problem	14	14
Power Problem	14	14
Material Fragmentation	12	12
Energy Output Problem	11	11
Insufficient Information	9	9
Adverse Event Without Identified Device or Use Problem	9	9
Overheating of Device	7	7
Defective Device	7	7
Sparking	6	6
Device Displays Incorrect Message	6	6
Peeled/Delaminated	6	6
Leak/Splash	5	5
Material Integrity Problem	5	5
Failure to Power Up	5	5
Output below Specifications	4	4
Loose or Intermittent Connection	4	4
Activation Problem	4	4
Smoking	4	4
Thermal Decomposition of Device	4	4
Noise, Audible	3	3
Loss of Power	3	3
Component Missing	3	3
No Device Output	2	2
Loss of or Failure to Bond	2	2
Display or Visual Feedback Problem	2	2
Appropriate Term/Code Not Available	2	2
Activation Failure	2	2
No Apparent Adverse Event	2	2
Delivered as Unsterile Product	2	2
Flare or Flash	2	2
Circuit Failure	2	2
Use of Device Problem	2	2
Disconnection	2	2
Compatibility Problem	2	2
Material Split, Cut or Torn	2	2
Unexpected Shutdown	2	2
Patient Device Interaction Problem	2	2
Fire	2	2
Intermittent Energy Output	2	2
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	202	202
Insufficient Information	106	106
No Known Impact Or Consequence To Patient	52	52
Hemorrhage/Bleeding	23	23
Superficial (First Degree) Burn	9	9
Burn(s)	9	9
Pain	6	6
Foreign Body In Patient	4	4
No Consequences Or Impact To Patient	4	4
Electric Shock	3	3
Unspecified Tissue Injury	3	3
Blood Loss	2	2
Intermenstrual Bleeding	2	2
No Patient Involvement	2	2
Laceration(s)	2	2
Distress	2	2
Impaired Healing	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Information	1	1
Abrasion	1	1
Burn, Thermal	1	1
Skin Tears	1	1
Partial thickness (Second Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CooperSurgical, Inc.	II	Nov-18-2021
2	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022