TPLC - Total Product Life Cycle

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Device	hemostatic device for endoscopic gastrointestinal use
Regulation Description	Hemostatic device for intraluminal gastrointestinal use.
Definition	Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.
Product Code	QAU
Regulation Number	878.4456
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation Failure	469	469
Obstruction of Flow	77	77
Complete Blockage	63	63
Adverse Event Without Identified Device or Use Problem	58	58
Fracture	52	52
Device Handling Problem	46	46
Entrapment of Device	34	34
Improper or Incorrect Procedure or Method	22	22
Material Twisted/Bent	18	18
Insufficient Flow or Under Infusion	10	10
Failure to Disconnect	9	9
Insufficient Information	6	6
Failure to Fire	5	5
Infusion or Flow Problem	4	4
Off-Label Use	3	3
Device Damaged by Another Device	3	3
Detachment of Device or Device Component	3	3
Human-Device Interface Problem	3	3
Defective Device	2	2
Therapeutic or Diagnostic Output Failure	2	2
Failure to Deliver	2	2
Extra Components	2	2
Activation, Positioning or Separation Problem	1	1
Material Split, Cut or Torn	1	1
Break	1	1
Physical Resistance/Sticking	1	1
Accessory Incompatible	1	1
Patient-Device Incompatibility	1	1
Difficult to Insert	1	1
Use of Device Problem	1	1
Component Missing	1	1
Gas/Air Leak	1	1
Inaccurate Flow Rate	1	1
Component Misassembled	1	1
Mechanical Jam	1	1
Premature Activation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	523	523
Gastrointestinal Hemorrhage	101	101
Device Embedded In Tissue or Plaque	26	26
Hemorrhage/Bleeding	15	15
Pain	10	10
Insufficient Information	8	8
Perforation	7	7
No Consequences Or Impact To Patient	6	6
No Known Impact Or Consequence To Patient	4	4
Foreign Body Sensation in Eye	2	2
Abdominal Pain	2	2
Hypersensitivity/Allergic reaction	2	2
Abdominal Distention	2	2
Laceration(s) of Esophagus	2	2
Cardiac Arrest	2	2
Unspecified Tissue Injury	2	2
Bruise/Contusion	2	2
High Blood Pressure/ Hypertension	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Respiratory Arrest	1	1
Adult Respiratory Distress Syndrome	1	1
Perforation of Esophagus	1	1
Embolism/Embolus	1	1
Exsanguination	1	1
Local Reaction	1	1
Obstruction/Occlusion	1	1
Anaphylactoid	1	1
Foreign Body In Patient	1	1
Fever	1	1
Hematemesis	1	1
Laceration(s)	1	1
Cough	1	1
Pseudoaneurysm	1	1
Ruptured Aneurysm	1	1
Hypoxia	1	1
Eye Pain	1	1
Unspecified Vascular Problem	1	1
Inadequate Pain Relief	1	1