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	78	78
Output Problem	49	50
Break	40	40
Mechanical Problem	29	29
Therapeutic or Diagnostic Output Failure	29	29
Failure to Cut	23	23
Melted	18	18
Nonstandard Device	17	17
Detachment of Device or Device Component	17	17
Defective Component	16	16
Electrical Power Problem	14	14
Power Problem	14	14
Material Fragmentation	12	12
Energy Output Problem	11	11
Adverse Event Without Identified Device or Use Problem	9	9
Insufficient Information	9	9
Peeled/Delaminated	8	8
Overheating of Device	8	8
Defective Device	8	9
Sparking	6	6
Device Displays Incorrect Message	6	6
Leak/Splash	5	5
Failure to Power Up	5	5
Activation Problem	5	5
Material Integrity Problem	5	5
Output below Specifications	4	4
Thermal Decomposition of Device	4	4
Loose or Intermittent Connection	4	4
Smoking	4	4
Component Missing	3	3
Loss of Power	3	3
Noise, Audible	3	3
Activation Failure	2	2
No Apparent Adverse Event	2	2
Appropriate Term/Code Not Available	2	2
Delivered as Unsterile Product	2	2
Display or Visual Feedback Problem	2	2
Arcing	2	2
Loss of or Failure to Bond	2	2
No Device Output	2	2
Material Twisted/Bent	2	2
Flare or Flash	2	2
Circuit Failure	2	2
Use of Device Problem	2	3
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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	214	214
Insufficient Information	107	107
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	7
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	3
No Patient Involvement	2	2
Laceration(s)	2	2
Distress	2	3
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