TPLC - Total Product Life Cycle

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Device	endoscopic tissue approximation device
Definition	To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
Product Code	OCW
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANCHORA MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
APOLLO ENDOSURGERY
	SUBSTANTIALLY EQUIVALENT	1
APOLLO ENDOSURGERY INC.
	SUBSTANTIALLY EQUIVALENT	2
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
ENDO TOOLS THERAPEUTICS S.A.
	SUBSTANTIALLY EQUIVALENT	1
HEALTH VALUE CREATION BV, TRADING AS CORPORIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MEDEON BIODESIGN, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	542	542
Break	494	494
Human-Device Interface Problem	270	270
Component or Accessory Incompatibility	138	138
Adverse Event Without Identified Device or Use Problem	122	122
Difficult to Open or Close	46	46
Entrapment of Device	43	43
Mechanical Problem	40	40
Insufficient Information	39	39
Physical Resistance/Sticking	26	26
Difficult to Remove	24	24
Mechanical Jam	21	21
Material Twisted/Bent	17	17
Failure to Align	16	16
Defective Device	14	14
Migration	9	9
Use of Device Problem	9	9
Therapeutic or Diagnostic Output Failure	8	8
Device-Device Incompatibility	8	8
Activation, Positioning or Separation Problem	8	8
Mechanics Altered	8	8
Patient-Device Incompatibility	6	6
Appropriate Term/Code Not Available	6	6
Material Split, Cut or Torn	6	6
Difficult to Insert	6	6
Unintended Ejection	6	6
Material Separation	6	6
Output Problem	5	5
Material Integrity Problem	5	5
Device Slipped	5	5
Improper or Incorrect Procedure or Method	4	4
No Apparent Adverse Event	4	4
Device Contamination with Chemical or Other Material	4	4
Misfire	4	4
Device Difficult to Setup or Prepare	4	4
Material Perforation	4	4
Premature Separation	3	3
Failure to Form Staple	3	3
Nonstandard Device	3	3
Fracture	3	3
Failure to Fire	3	3
Product Quality Problem	3	3
Dull, Blunt	3	3
Component Missing	3	3
Positioning Problem	3	3
Defective Component	3	3
Patient Device Interaction Problem	2	2
Device Dislodged or Dislocated	2	2
Difficult to Advance	2	2
Material Puncture/Hole	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	437	437
No Consequences Or Impact To Patient	208	208
Insufficient Information	150	150
Foreign Body In Patient	119	119
Unintended Radiation Exposure	113	113
No Known Impact Or Consequence To Patient	72	72
No Code Available	61	61
Device Embedded In Tissue or Plaque	51	51
Unspecified Tissue Injury	44	44
Hemorrhage/Bleeding	40	40
No Information	30	30
Radiation Exposure, Unintended	27	27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	26	26
Pain	18	18
Perforation	14	14
Tissue Damage	12	12
Abdominal Pain	11	11
Patient Problem/Medical Problem	11	11
Perforation of Esophagus	11	11
No Patient Involvement	9	9
Vomiting	8	8
Pulmonary Embolism	8	8
Gastrointestinal Hemorrhage	8	8
Unspecified Infection	7	7
Nausea	6	6
Failure of Implant	6	6
Fever	5	5
Pneumothorax	5	5
Abscess	5	5
Hematoma	5	5
Ulcer	5	5
Injury	4	4
Death	4	4
Pancreatitis	4	4
Perforation of Vessels	4	4
Organ Dehiscence	4	4
Bowel Perforation	4	4
Sepsis	4	4
Emotional Changes	3	3
Fistula	3	3
Anxiety	3	3
Fatigue	3	3
Laceration(s) of Esophagus	3	3
Failure to Anastomose	3	3
Cramp(s) /Muscle Spasm(s)	3	3
Hemostasis	3	3
Cardiac Arrest	3	3
Peritonitis	3	3
Internal Organ Perforation	3	3
Wound Dehiscence	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien LP	II	Feb-06-2024