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
Therapeutic or Diagnostic Output Failure	29	29
Mechanical Problem	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
Power Problem	14	14
Electrical 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
Defective Device	7	7
Overheating of Device	7	7
Device Displays Incorrect Message	6	6
Sparking	6	6
Peeled/Delaminated	6	6
Leak/Splash	5	5
Failure to Power Up	5	5
Material Integrity Problem	5	5
Thermal Decomposition of Device	4	4
Loose or Intermittent Connection	4	4
Output below Specifications	4	4
Smoking	4	4
Activation Problem	4	4
Noise, Audible	3	3
Component Missing	3	3
Loss of Power	3	3
Patient Device Interaction Problem	2	2
Activation Failure	2	2
Appropriate Term/Code Not Available	2	2
No Apparent Adverse Event	2	2
Material Split, Cut or Torn	2	2
Unexpected Shutdown	2	2
Intermittent Energy Output	2	2
Use of Device Problem	2	2
Fire	2	2
Display or Visual Feedback Problem	2	2
Disconnection	2	2
Circuit Failure	2	2
Loss of or Failure to Bond	2	2
Compatibility Problem	2	2
Flare or Flash	2	2
No Device Output	2	2
Delivered as Unsterile Product	2	2
Excessive Heating	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
Burn(s)	9	9
Superficial (First Degree) Burn	9	9
Pain	6	6
No Consequences Or Impact To Patient	4	4
Foreign Body In Patient	4	4
Unspecified Tissue Injury	3	3
Electric Shock	3	3
Laceration(s)	2	2
Distress	2	2
Blood Loss	2	2
No Patient Involvement	2	2
Intermenstrual Bleeding	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Impaired Healing	1	1
Skin Tears	1	1
Burn, Thermal	1	1
Abrasion	1	1
Partial thickness (Second Degree) Burn	1	1
No Information	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