TPLC - Total Product Life Cycle

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Device	endoscopic tissue approximation device
Regulation Description	Endoscope and accessories.
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, INC.
	SUBSTANTIALLY EQUIVALENT	2
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
ENDO TOOLS THERAPEUTICS S.A.
	SUBSTANTIALLY EQUIVALENT	1
ENVISION ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	1
HEALTH VALUE CREATION B.V., TRADING AS CORPORIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MEDEON BIODESIGN, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	547	566
Detachment of Device or Device Component	505	514
Human-Device Interface Problem	215	218
Adverse Event Without Identified Device or Use Problem	140	144
Component or Accessory Incompatibility	111	112
Difficult to Open or Close	51	51
Entrapment of Device	50	51
Insufficient Information	38	39
Device-Device Incompatibility	37	37
Difficult to Remove	31	34
Mechanical Problem	28	28
Material Twisted/Bent	25	25
Mechanical Jam	21	21
Activation Failure	18	18
Defective Device	17	18
Failure to Align	16	16
Material Integrity Problem	15	15
Failure to Cut	13	13
Physical Resistance/Sticking	12	12
Use of Device Problem	12	12
Mechanics Altered	10	10
Migration	9	9
Difficult to Advance	8	8
Therapeutic or Diagnostic Output Failure	7	7
Device Slipped	7	7
Patient-Device Incompatibility	7	7
Material Separation	6	6
Unintended Ejection	6	6
Difficult to Insert	6	6
Activation, Positioning or Separation Problem	6	7
Material Split, Cut or Torn	6	6
Output Problem	5	5
Misfire	5	5
No Apparent Adverse Event	5	5
Positioning Problem	4	4
Appropriate Term/Code Not Available	4	4
Material Perforation	4	4
Product Quality Problem	3	3
Material Deformation	3	3
Improper or Incorrect Procedure or Method	3	3
Firing Problem	3	3
Failure to Form Staple	3	3
Premature Separation	3	3
Dull, Blunt	3	3
Material Frayed	2	2
Leak/Splash	2	2
Fracture	2	2
Fluid/Blood Leak	2	2
Device Difficult to Setup or Prepare	2	2
Patient Device Interaction Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	540	552
Insufficient Information	162	168
Foreign Body In Patient	157	159
Unintended Radiation Exposure	144	147
No Consequences Or Impact To Patient	66	67
Unspecified Tissue Injury	43	44
Hemorrhage/Bleeding	41	41
Device Embedded In Tissue or Plaque	37	41
No Code Available	30	30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	27
No Information	16	16
No Known Impact Or Consequence To Patient	15	15
Perforation	14	14
Pain	14	14
Abdominal Pain	12	12
Perforation of Esophagus	11	11
Vomiting	9	9
Tissue Damage	8	8
Radiation Exposure, Unintended	8	8
Gastrointestinal Hemorrhage	8	8
Unspecified Infection	7	7
Failure of Implant	6	6
Pulmonary Embolism	6	6
Ulcer	6	6
Nausea	6	6
Hematoma	5	5
Sepsis	5	5
Fever	5	5
Patient Problem/Medical Problem	5	5
Bowel Perforation	4	4
Pneumothorax	4	4
Laceration(s)	4	4
Pancreatitis	4	4
Organ Dehiscence	4	4
Abscess	4	4
Perforation of Vessels	4	4
Laceration(s) of Esophagus	3	3
Tachycardia	3	3
Wound Dehiscence	3	3
Emotional Changes	3	3
Distress	3	3
Tissue Breakdown	3	3
Cardiac Arrest	3	3
Cramp(s) /Muscle Spasm(s)	3	3
Pneumonia	3	3
No Patient Involvement	3	3
Discomfort	3	3
Thrombosis/Thrombus	2	2
Obstruction/Occlusion	2	2
Sleep Dysfunction	2	2

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