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	84	84
Mechanical Problem	24	24
Detachment of Device or Device Component	15	15
Electrical Power Problem	14	14
Break	12	12
Material Fragmentation	12	12
Melted	11	11
Output Problem	8	8
Peeled/Delaminated	8	8
Overheating of Device	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Use of Device Problem	2	2
Sparking	2	2
Fire	2	2
Insufficient Device Problem Information	2	2
Arcing	1	1
Failure to Cut	1	1
Loss of Power	1	1
Unintended Electrical Shock	1	1
Flare or Flash	1	1
Material Twisted/Bent	1	1
Circuit Failure	1	1
Fracture	1	1
Compatibility Problem	1	1
Material Puncture/Hole	1	1
Patient Device Interaction Problem	1	1
Disconnection	1	1
Defective Component	1	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	208	209
Insufficient Information	98	98
Hemorrhage/Blood Loss/Bleeding	21	21
Burn(s)	10	10
Superficial (First Degree) Burn	9	9
Pain	6	7
Foreign Body In Patient	5	5
Unspecified Tissue Injury	3	3
Electric Shock	2	2
Laceration(s)	2	2
Distress	2	3
Intermenstrual Bleeding	2	3
Unintended Radiation Exposure	1	1
Skin Tears	1	1
Impaired Healing	1	1
Partial thickness (Second Degree) Burn	1	1
Abrasion	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	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