TPLC - Total Product Life Cycle

show TPLC since

Device	clamp, surgical, general & plastic surgery
Product Code	GDJ
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Misassembled	44	44
Break	28	28
Failure to Fire	21	21
Detachment of Device or Device Component	17	17
Failure to Form Staple	12	12
Fracture	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Difficult to Open or Close	8	8
Entrapment of Device	5	5
Difficult to Remove	4	4
Device Slipped	2	2
Unraveled Material	2	2
Misfire	2	2
Mechanical Problem	1	1
Device Fell	1	1
Mechanics Altered	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Use of Device Problem	1	1
Component Missing	1	1
Device Difficult to Setup or Prepare	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	111	111
No Consequences Or Impact To Patient	12	12
Insufficient Information	11	11
Unspecified Tissue Injury	6	6
No Known Impact Or Consequence To Patient	5	5
Failure to Anastomose	3	3
Hemorrhage/Bleeding	3	3
No Patient Involvement	2	2
Tissue Breakdown	2	2
No Information	1	1
Peritonitis	1	1
Post Operative Wound Infection	1	1
Foreign Body In Patient	1	1
Laceration(s)	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