TPLC - Total Product Life Cycle

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Device	instrument, surgical, disposable
Regulation Description	Manual surgical instrument for general use.
Product Code	KDC
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	27	27
Break	15	15
Dull, Blunt	7	7
Adverse Event Without Identified Device or Use Problem	6	6
Unsealed Device Packaging	5	5
Delivered as Unsterile Product	3	3
Insufficient Device Problem Information	2	2
Fracture	2	2
Mechanical Jam	2	2
Material Integrity Problem	2	2
Packaging Problem	1	1
No Apparent Adverse Event	1	1
Leak/Splash	1	1
Contamination	1	1
Material Too Soft/Flexible	1	1
Use of Device Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Fail-Safe Did Not Operate	1	1
Defective Component	1	1
Tear, Rip or Hole in Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	67	67
Hemorrhage/Blood Loss/Bleeding	3	3
Insufficient Information	3	3
Foreign Body In Patient	2	2
Obstruction/Occlusion	2	2
Perforation of Vessels	2	2
Bacterial Infection	2	2
Failure to Anastomose	1	1
Injury	1	1
Pocket Erosion	1	1
Perforation	1	1
Gastrointestinal Hemorrhage	1	1
Fistula	1	1
Failure of Implant	1	1
Pain	1	1
Menstrual Irregularities	1	1
Post Operative Wound Infection	1	1
Unspecified Tissue Injury	1	1
Laceration(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	May-15-2025
2	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024
3	Medical Action Industries, Inc. 306	II	Dec-22-2022
4	Medical Action Industries, Inc. 306	II	Jun-24-2021