TPLC - Total Product Life Cycle

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Device	tube, gastro-enterostomy
Regulation Description	Gastrointestinal tube and accessories.
Product Code	KGC
Regulation Number	876.5980
Device Class	2

Premarket Reviews
Manufacturer	Decision
APPLIED MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
COAPTECH INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	191	191
Fracture	33	33
Adverse Event Without Identified Device or Use Problem	26	26
Fluid/Blood Leak	24	24
Detachment of Device or Device Component	19	19
Premature Separation	12	12
Unintended Movement	11	11
Loosening of Implant Not Related to Bone-Ingrowth	8	8
Entrapment of Device	6	6
Migration	6	6
Fitting Problem	5	5
Material Deformation	5	5
Material Fragmentation	5	5
Deformation Due to Compressive Stress	4	4
Material Separation	4	4
Material Rupture	4	4
Separation Failure	4	4
Material Integrity Problem	4	4
Improper or Incorrect Procedure or Method	3	3
Difficult to Open or Close	3	3
Appropriate Term/Code Not Available	3	3
Device Dislodged or Dislocated	3	3
Malposition of Device	3	3
Defective Component	3	3
Difficult to Remove	3	3
Material Twisted/Bent	2	2
Obstruction of Flow	2	2
Difficult to Insert	2	2
Insufficient Information	2	2
Difficult to Advance	2	2
Reflux within Device	2	2
Migration or Expulsion of Device	2	2
Separation Problem	2	2
Device Slipped	2	2
Leak/Splash	2	2
Disconnection	2	2
Defective Device	1	1
Patient-Device Incompatibility	1	1
Positioning Failure	1	1
Use of Device Problem	1	1
Difficult to Flush	1	1
Dent in Material	1	1
Gas/Air Leak	1	1
Restricted Flow rate	1	1
Crack	1	1
Physical Resistance/Sticking	1	1
Failure to Eject	1	1
Off-Label Use	1	1
Mechanical Problem	1	1
Failure to Infuse	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	114	114
No Consequences Or Impact To Patient	69	69
Insufficient Information	49	49
Foreign Body In Patient	46	46
No Known Impact Or Consequence To Patient	21	21
Device Embedded In Tissue or Plaque	15	15
Peritonitis	12	12
Pain	11	11
Abdominal Pain	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Unspecified Infection	8	8
Hemorrhage/Bleeding	7	7
No Code Available	6	6
Skin Inflammation/ Irritation	4	4
Inflammation	4	4
Perforation	4	4
Seizures	3	3
Erosion	3	3
Bacterial Infection	3	3
Tachycardia	3	3
Fever	3	3
Internal Organ Perforation	2	2
Granuloma	2	2
Fluid Discharge	2	2
Erythema	2	2
Post Operative Wound Infection	2	2
Purulent Discharge	2	2
Abdominal Distention	2	2
Abdominal Cramps	2	2
Bowel Perforation	2	2
Gastrointestinal Hemorrhage	2	2
Sepsis	2	2
Skin Infection	2	2
Cramp(s) /Muscle Spasm(s)	1	1
Local Reaction	1	1
Unspecified Blood or Lymphatic problem	1	1
Rash	1	1
Flatus	1	1
Discomfort	1	1
Skin Inflammation	1	1
Hematoma	1	1
Abscess	1	1
Bradycardia	1	1
Necrosis	1	1
Unspecified Gastrointestinal Problem	1	1
Perforation of Vessels	1	1
Cough	1	1
Hypersensitivity/Allergic reaction	1	1
Death	1	1
Infarction, Cerebral	1	1