TPLC - Total Product Life Cycle

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Device	clamp, surgical, general & plastic surgery
Regulation Description	Manual surgical instrument for general use.
Product Code	GDJ
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Misassembled	44	44
Failure to Fire	29	29
Break	28	28
Detachment of Device or Device Component	15	15
Failure to Form Staple	11	11
Fracture	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Difficult to Open or Close	8	8
Entrapment of Device	8	8
Misfire	5	5
Difficult to Remove	3	3
Material Deformation	3	3
Mechanics Altered	2	2
Device Slipped	2	2
Unraveled Material	2	2
Component Missing	1	1
Patient-Device Incompatibility	1	1
Material Fragmentation	1	1
Material Frayed	1	1
Mechanical Problem	1	1
Contamination	1	1
Delivered as Unsterile Product	1	1
Device Difficult to Setup or Prepare	1	1
Insufficient Information	1	1
Device Fell	1	1
Material Integrity Problem	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	138	138
Insufficient Information	18	18
Failure to Anastomose	8	8
Unspecified Tissue Injury	6	6
Tissue Breakdown	6	6
Hemorrhage/Bleeding	4	4
Laceration(s)	2	2
Peritonitis	1	1
Post Operative Wound Infection	1	1
Foreign Body In Patient	1	1
Abscess	1	1
Ascites	1	1
Fistula	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Perfusion Systems	II	Jul-23-2024
2	Medtronic Perfusion Systems	II	May-10-2024
3	Sklar Instruments	II	Jan-16-2025