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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	519	535
Detachment of Device or Device Component	466	475
Human-Device Interface Problem	190	193
Adverse Event Without Identified Device or Use Problem	142	146
Component or Accessory Incompatibility	98	99
Device-Device Incompatibility	49	49
Difficult to Open or Close	47	47
Material Twisted/Bent	44	44
Entrapment of Device	38	39
Insufficient Information	36	37
Activation Failure	33	33
Difficult to Remove	26	26
Failure to Align	23	23
Mechanical Problem	23	23
Failure to Cut	21	21
Material Integrity Problem	15	15
Defective Device	13	14
Mechanical Jam	12	12
Difficult to Advance	11	11
Migration	9	9
Mechanics Altered	9	9
Use of Device Problem	9	9
Physical Resistance/Sticking	8	8
Device Slipped	8	8
Unintended Ejection	6	6
Output Problem	5	5
No Apparent Adverse Event	5	5
Material Split, Cut or Torn	5	5
Material Separation	5	5
Activation, Positioning or Separation Problem	5	5
Patient-Device Incompatibility	4	4
Appropriate Term/Code Not Available	4	4
Therapeutic or Diagnostic Output Failure	4	4
Misfire	4	4
Material Frayed	4	4
Material Perforation	4	4
Firing Problem	3	3
Product Quality Problem	3	3
Difficult to Insert	3	3
Material Deformation	3	3
Fracture	2	2
Premature Separation	2	2
Failure to Fire	2	2
Fluid/Blood Leak	2	2
Device Difficult to Setup or Prepare	2	2
Positioning Problem	2	2
Leak/Splash	2	2
Component Missing	1	2
Battery Problem	1	1
Material Fragmentation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	723	735
Foreign Body In Patient	186	188
Insufficient Information	176	182
Unintended Radiation Exposure	166	169
Hemorrhage/Bleeding	45	45
Unspecified Tissue Injury	41	42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	27
Device Embedded In Tissue or Plaque	23	24
Perforation	18	18
Pain	16	16
Abdominal Pain	14	14
Tissue Breakdown	10	10
Vomiting	9	9
Perforation of Esophagus	8	8
Gastrointestinal Hemorrhage	8	8
Laceration(s)	7	7
Nausea	6	6
Failure of Implant	6	6
Unspecified Infection	6	6
Pulmonary Embolism	6	6
Ulcer	6	6
Hematoma	5	5
Inflammation	4	4
Perforation of Vessels	4	4
Sepsis	4	4
Pancreatitis	4	4
Bowel Perforation	4	4
Cramp(s) /Muscle Spasm(s)	3	3
Pneumonia	3	3
Distress	3	3
Discomfort	3	3
Emotional Changes	3	3
Fever	3	3
Wound Dehiscence	3	3
Cardiac Arrest	3	3
Chest Pain	2	2
Dehydration	2	2
Diarrhea	2	2
Abscess	2	2
Fistula	2	2
Fatigue	2	2
Liver Damage/Dysfunction	2	2
Deformity/ Disfigurement	2	2
Depression	2	2
Laceration(s) of Esophagus	2	2
Obstruction/Occlusion	2	2
Post Operative Wound Infection	2	2
Sleep Dysfunction	2	2
Lethargy	2	2
Ascites	2	2

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