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	83	83
Output Problem	47	48
Mechanical Problem	28	28
Break	27	27
Therapeutic or Diagnostic Output Failure	18	18
Nonstandard Device	16	16
Detachment of Device or Device Component	15	15
Melted	14	14
Electrical Power Problem	14	14
Failure to Cut	14	14
Defective Component	12	13
Material Fragmentation	12	12
Peeled/Delaminated	8	8
Power Problem	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Energy Output Problem	7	7
Sparking	5	5
Overheating of Device	5	5
Defective Device	5	6
Disconnection	4	4
Activation Problem	4	4
Insufficient Information	4	4
Leak/Splash	3	3
Output below Specifications	3	3
Device Displays Incorrect Message	3	3
Use of Device Problem	3	4
Loose or Intermittent Connection	3	3
Activation Failure	2	2
No Apparent Adverse Event	2	2
Material Twisted/Bent	2	2
Component Missing	2	2
Failure to Power Up	2	2
Display or Visual Feedback Problem	2	2
Patient Device Interaction Problem	2	2
Loss of Power	2	2
Material Integrity Problem	2	2
Arcing	2	2
Intermittent Energy Output	2	2
Fire	2	2
Compatibility Problem	2	2
Circuit Failure	2	2
Improper or Incorrect Procedure or Method	1	1
Firing Problem	1	1
Difficult to Open or Close	1	1
Self-Activation or Keying	1	1
Mechanical Jam	1	1
Loss of or Failure to Bond	1	1
No Device Output	1	1
Temperature Problem	1	1
Excessive Heating	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	202	203
Insufficient Information	98	98
Hemorrhage/Bleeding	21	21
Burn(s)	10	10
Superficial (First Degree) Burn	9	9
Pain	6	7
Foreign Body In Patient	4	4
Unspecified Tissue Injury	3	3
Electric Shock	2	2
Intermenstrual Bleeding	2	3
Laceration(s)	2	2
Distress	2	3
Impaired Healing	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Abrasion	1	1
Skin Tears	1	1
Partial thickness (Second Degree) Burn	1	1
Unintended Radiation Exposure	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