TPLC - Total Product Life Cycle

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Device	hemostatic device for endoscopic 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	346	346
Failure to Fire	182	182
Obstruction of Flow	99	99
Complete Blockage	60	60
Adverse Event Without Identified Device or Use Problem	53	53
Device Handling Problem	41	41
Improper or Incorrect Procedure or Method	39	39
Entrapment of Device	30	30
Gas/Air Leak	21	21
Fracture	16	16
Use of Device Problem	10	10
Insufficient Flow or Under Infusion	9	9
Material Twisted/Bent	8	8
Crack	7	7
Explosion	7	7
Failure to Disconnect	5	5
Insufficient Information	4	4
Partial Blockage	4	4
Failure to Deliver	4	4
Off-Label Use	4	4
Infusion or Flow Problem	3	3
Patient Device Interaction Problem	3	3
Activation Problem	3	3
Defective Device	2	2
Difficult to Remove	2	2
Material Separation	2	2
Premature Activation	2	2
Inaccurate Delivery	2	2
Break	2	2
Material Fragmentation	1	1
Difficult to Insert	1	1
Inaccurate Flow Rate	1	1
Component Missing	1	1
Accessory Incompatible	1	1
Human-Device Interface Problem	1	1
Activation, Positioning or Separation Problem	1	1
Detachment of Device or Device Component	1	1
Device Damaged by Another Device	1	1
Mechanical Jam	1	1
Appropriate Term/Code Not Available	1	1
Therapeutic or Diagnostic Output Failure	1	1
Component Misassembled	1	1
Physical Resistance/Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	315	315
No Consequences Or Impact To Patient	231	231
Gastrointestinal Hemorrhage	74	74
No Patient Involvement	37	37
No Known Impact Or Consequence To Patient	20	20
Device Embedded In Tissue or Plaque	18	18
Hemorrhage/Bleeding	17	17
Hemostasis	11	11
Insufficient Information	7	7
Perforation	4	4
Death	3	3
Exsanguination	3	3
Foreign Body Sensation in Eye	2	2
Bruise/Contusion	2	2
Hypersensitivity/Allergic reaction	2	2
Laceration(s)	2	2
Unspecified Tissue Injury	2	2
Pain	1	1
Local Reaction	1	1
Therapeutic Effects, Unexpected	1	1
Bowel Perforation	1	1
Hematemesis	1	1
No Information	1	1
Ruptured Aneurysm	1	1
Embolism/Embolus	1	1
Unspecified Vascular Problem	1	1
Respiratory Arrest	1	1
Eye Pain	1	1
High Blood Pressure/ Hypertension	1	1
Unspecified Infection	1	1
Inflammation	1	1
Irritation	1	1
Cardiac Arrest	1	1
Ulcer	1	1
Laceration(s) of Esophagus	1	1
Perforation of Esophagus	1	1
Obstruction/Occlusion	1	1
Chest Tightness/Pressure	1	1
Abdominal Distention	1	1
Pseudoaneurysm	1	1