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	489	489
Obstruction of Flow	83	83
Complete Blockage	67	67
Adverse Event Without Identified Device or Use Problem	59	59
Fracture	53	53
Device Handling Problem	47	47
Entrapment of Device	35	35
Improper or Incorrect Procedure or Method	24	24
Material Twisted/Bent	18	18
Insufficient Flow or Under Infusion	10	10
Failure to Disconnect	9	9
Insufficient Information	6	6
Infusion or Flow Problem	5	5
Failure to Fire	5	5
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
Device Contaminated During Manufacture or Shipping	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
Moisture Damage	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	535	535
Gastrointestinal Hemorrhage	111	111
Device Embedded In Tissue or Plaque	27	27
Hemorrhage/Bleeding	15	15
Pain	10	10
Perforation	8	8
Insufficient Information	8	8
No Consequences Or Impact To Patient	6	6
No Known Impact Or Consequence To Patient	4	4
Abdominal Pain	2	2
Foreign Body Sensation in Eye	2	2
Hypersensitivity/Allergic reaction	2	2
Abdominal Distention	2	2
Laceration(s) of Esophagus	2	2
Cardiac Arrest	2	2
Laceration(s)	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
Adult Respiratory Distress Syndrome	1	1
Respiratory Arrest	1	1
Perforation of Esophagus	1	1
Exsanguination	1	1
Embolism/Embolus	1	1
Local Reaction	1	1
Anaphylactoid	1	1
Obstruction/Occlusion	1	1
Fever	1	1
Foreign Body In Patient	1	1
Hematemesis	1	1
Cough	1	1
Hypoxia	1	1
Pseudoaneurysm	1	1
Ruptured Aneurysm	1	1
Inadequate Pain Relief	1	1
Unspecified Vascular Problem	1	1
Eye Pain	1	1
Aspiration Pneumonitis	1	1