TPLC - Total Product Life Cycle

show TPLC since

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	20	20
Break	17	17
Adverse Event Without Identified Device or Use Problem	6	6
Unsealed Device Packaging	4	4
Defective Component	3	3
Delivered as Unsterile Product	3	3
Insufficient Information	2	2
Contamination	2	2
Leak/Splash	1	1
Device Markings/Labelling Problem	1	1
Patient-Device Incompatibility	1	1
Therapeutic or Diagnostic Output Failure	1	1
Use of Device Problem	1	1
Packaging Problem	1	1
Device Contamination with Chemical or Other Material	1	1
No Apparent Adverse Event	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	47	47
No Known Impact Or Consequence To Patient	3	3
Hemorrhage/Bleeding	3	3
Obstruction/Occlusion	2	2
Injury	2	2
Foreign Body In Patient	2	2
Insufficient Information	2	2
Bacterial Infection	2	2
Menstrual Irregularities	1	1
Failure of Implant	1	1
Gastrointestinal Hemorrhage	1	1
Perforation	1	1
Post Operative Wound Infection	1	1
No Patient Involvement	1	1
Laceration(s)	1	1
Pain	1	1
Failure to Anastomose	1	1
Perforation of Vessels	1	1
Unspecified Tissue Injury	1	1
No Consequences Or Impact To Patient	1	1
Pocket Erosion	1	1
Fistula	1	1

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