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	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	265	267
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	20
Premature Separation	12	12
Unintended Movement	11	11
Migration	9	9
Loosening of Implant Not Related to Bone-Ingrowth	8	8
Malposition of Device	7	7
Entrapment of Device	6	6
Fitting Problem	5	5
Material Deformation	5	5
Material Fragmentation	5	5
Deformation Due to Compressive Stress	4	4
Device Dislodged or Dislocated	4	4
Material Separation	4	4
Material Rupture	4	4
Separation Failure	4	4
Difficult to Remove	4	4
Material Integrity Problem	4	5
Improper or Incorrect Procedure or Method	3	3
Difficult to Open or Close	3	3
Appropriate Term/Code Not Available	3	3
Material Twisted/Bent	3	3
Defective Component	3	3
Separation Problem	3	3
Insufficient Information	2	2
Inadequate Instructions for Healthcare Professional	2	2
Difficult to Advance	2	2
Difficult to Insert	2	2
Obstruction of Flow	2	2
Reflux within Device	2	2
Migration or Expulsion of Device	2	2
Device Slipped	2	2
Leak/Splash	2	2
Disconnection	2	2
Defective Device	1	1
Patient-Device Incompatibility	1	1
Difficult to Flush	1	1
Positioning Failure	1	1
Use of Device Problem	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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	167	167
No Consequences Or Impact To Patient	69	69
Insufficient Information	63	64
Foreign Body In Patient	52	53
No Known Impact Or Consequence To Patient	21	21
Device Embedded In Tissue or Plaque	18	18
Peritonitis	14	14
Pain	13	13
Abdominal Pain	11	11
Unspecified Infection	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Hemorrhage/Bleeding	10	10
Skin Inflammation/ Irritation	7	7
No Code Available	6	6
Bacterial Infection	4	4
Fever	4	4
Inflammation	4	4
Perforation	4	4
Erosion	3	3
Tachycardia	3	3
Abdominal Distention	3	3
Sepsis	3	3
Seizures	3	3
Abdominal Cramps	2	2
Purulent Discharge	2	2
Post Operative Wound Infection	2	2
Bowel Perforation	2	2
Erythema	2	2
Gastrointestinal Hemorrhage	2	2
Abscess	2	2
Fluid Discharge	2	2
Cough	2	2
Skin Infection	2	2
Granuloma	2	2
Internal Organ Perforation	2	2
Local Reaction	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Hematoma	1	1
Unspecified Blood or Lymphatic problem	1	1
Necrosis	1	1
Rash	1	1
Unspecified Gastrointestinal Problem	1	1
Flatus	1	1
Vomiting	1	1
Discomfort	1	1
Skin Inflammation	1	1
Bradycardia	1	1
Perforation of Vessels	1	2
Hypersensitivity/Allergic reaction	1	1
Death	1	1