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	2
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	632	651
Detachment of Device or Device Component	556	565
Human-Device Interface Problem	226	229
Adverse Event Without Identified Device or Use Problem	172	176
Component or Accessory Incompatibility	112	113
Activation Failure	83	83
Difficult to Open or Close	58	58
Failure to Cut	57	57
Entrapment of Device	53	54
Device-Device Incompatibility	52	52
Material Twisted/Bent	51	51
Insufficient Information	38	39
Difficult to Remove	36	39
Mechanical Problem	30	30
Failure to Align	24	24
Mechanical Jam	21	21
Defective Device	18	19
Material Integrity Problem	17	17
Use of Device Problem	15	15
Difficult to Advance	13	13
Physical Resistance/Sticking	12	12
Failure to Form Staple	10	10
Device Slipped	10	10
Mechanics Altered	10	10
Migration	9	9
Therapeutic or Diagnostic Output Failure	8	8
Patient-Device Incompatibility	7	7
No Apparent Adverse Event	7	7
Misfire	7	7
Failure to Fire	7	7
Material Split, Cut or Torn	6	6
Activation, Positioning or Separation Problem	6	7
Difficult to Insert	6	6
Material Separation	6	6
Unintended Ejection	6	6
Output Problem	5	5
Appropriate Term/Code Not Available	4	4
Positioning Problem	4	4
Material Perforation	4	4
Material Frayed	4	4
Premature Separation	3	3
Firing Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Device Dislodged or Dislocated	3	3
Product Quality Problem	3	3
Material Deformation	3	3
Dull, Blunt	3	3
Ejection Problem	3	3
Patient Device Interaction Problem	3	3
Device Difficult to Setup or Prepare	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	877	889
Foreign Body In Patient	213	215
Insufficient Information	188	194
Unintended Radiation Exposure	180	183
No Consequences Or Impact To Patient	66	67
Hemorrhage/Bleeding	50	50
Unspecified Tissue Injury	45	46
Device Embedded In Tissue or Plaque	38	42
No Code Available	30	30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	27
Perforation	19	19
Pain	16	16
No Information	16	16
No Known Impact Or Consequence To Patient	15	15
Abdominal Pain	14	14
Perforation of Esophagus	13	13
Tissue Breakdown	10	10
Vomiting	9	9
Unspecified Infection	8	8
Laceration(s)	8	8
Tissue Damage	8	8
Radiation Exposure, Unintended	8	8
Gastrointestinal Hemorrhage	8	8
Ulcer	6	6
Hematoma	6	6
Nausea	6	6
Failure of Implant	6	6
Pulmonary Embolism	6	6
Sepsis	5	5
Fever	5	5
Patient Problem/Medical Problem	5	5
Bowel Perforation	4	4
Organ Dehiscence	4	4
Inflammation	4	4
Perforation of Vessels	4	4
Abscess	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Pancreatitis	4	4
Pneumothorax	4	4
Wound Dehiscence	4	4
Emotional Changes	3	3
Tachycardia	3	3
Pneumonia	3	3
Laceration(s) of Esophagus	3	3
Distress	3	3
No Patient Involvement	3	3
Cardiac Arrest	3	3
Discomfort	3	3
Deformity/ Disfigurement	2	2
Ascites	2	2