TPLC - Total Product Life Cycle

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Device	blade, scalpel
Regulation Description	Manual surgical instrument for general use.
Product Code	GES
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	37	37
Unsealed Device Packaging	19	19
Insufficient Device Problem Information	19	19
Material Integrity Problem	10	10
Fracture	10	10
Dull, Blunt	6	6
Fail-Safe Did Not Operate	3	3
Difficult to Open or Close	3	3
Device Contaminated During Manufacture or Shipping	2	2
Difficult to Remove	2	2
Material Fragmentation	2	2
Difficult to Insert	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Packaging Problem	2	2
Device Handling Problem	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Difficult to Open or Remove Packaging Material	1	1
Contamination /Decontamination Problem	1	1
Degraded	1	1
Fail-Safe Problem	1	1
Failure to Cut	1	1
Delivered as Unsterile Product	1	1
Product Quality Problem	1	1
Material Separation	1	1
Detachment of Device or Device Component	1	1
No Apparent Adverse Event	1	1
Nonstandard Device	1	1
Extra Components	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	140	140
Insufficient Information	22	22
Foreign Body In Patient	12	12
Laceration(s)	6	6
Device Embedded In Tissue or Plaque	3	3
Unspecified Skin and Subcutaneous Tissue Problem	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Southmedic, Inc.	II	Nov-23-2022