TPLC - Total Product Life Cycle

• Device: tube, gastro-enterostomy
• Product Code: KGC
• Regulation Number: 876.5980
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
APPLIED MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
COAPTECH LLC
	SUBSTANTIALLY EQUIVALENT	1
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	1
FIDMI MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2017	102	102
2018	84	84
2019	90	90
2020	118	118
2021	73	73
2022	45	45

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	265	265
Fluid/Blood Leak	38	38
Fracture	34	34
Leak/Splash	32	32
Detachment of Device or Device Component	29	29
Adverse Event Without Identified Device or Use Problem	23	23
Detachment Of Device Component	16	16
Migration or Expulsion of Device	12	12
Material Deformation	7	7
Material Integrity Problem	7	7
Migration	6	6
Device Dislodged or Dislocated	6	6
Fitting Problem	6	6
Material Fragmentation	6	6
Material Rupture	5	5
Defective Component	5	5
Separation Failure	4	4
Improper or Incorrect Procedure or Method	4	4
Difficult to Open or Close	4	4
Unintended Movement	4	4
Delivered as Unsterile Product	4	4
Failure to Infuse	3	3
Material Discolored	3	3
Disconnection	3	3
Entrapment of Device	3	3
Device Operates Differently Than Expected	3	3
Difficult to Advance	3	3
Deformation Due to Compressive Stress	3	3
Appropriate Term/Code Not Available	2	2
Material Twisted/Bent	2	2
Hole In Material	2	2
Obstruction of Flow	2	2
Failure to Advance	2	2
Material Separation	2	2
Occlusion Within Device	2	2
Deflation Problem	2	2
Mechanical Problem	2	2
Reflux within Device	2	2
Difficult to Remove	2	2
Unsealed Device Packaging	1	1
Inadequacy of Device Shape and/or Size	1	1
Sticking	1	1
Stretched	1	1
Unexpected Therapeutic Results	1	1
Device Inoperable	1	1
Dent in Material	1	1
Inflation Problem	1	1
Difficult to Insert	1	1
Loose or Intermittent Connection	1	1
Difficult to Flush	1	1
Restricted Flow rate	1	1
Material Disintegration	1	1
Component Falling	1	1
Burst Container or Vessel	1	1
Complete Blockage	1	1
Material Split, Cut or Torn	1	1
Physical Resistance/Sticking	1	1
Separation Problem	1	1
Premature Separation	1	1
Component or Accessory Incompatibility	1	1
Connection Problem	1	1
Component Missing	1	1
Defective Device	1	1
Malposition of Device	1	1
Patient-Device Incompatibility	1	1
Device Contamination with Chemical or Other Material	1	1
Gas/Air Leak	1	1
Manufacturing, Packaging or Shipping Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	164	164
No Known Impact Or Consequence To Patient	143	143
No Clinical Signs, Symptoms or Conditions	56	56
Foreign Body In Patient	37	37
No Code Available	15	15
Insufficient Information	13	13
Pain	13	13
Device Embedded In Tissue or Plaque	12	12
Unspecified Infection	9	9
Peritonitis	8	8
No Information	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Perforation	6	6
Swelling	5	5
Erythema	5	5
Bowel Perforation	5	5
Hemorrhage/Bleeding	4	4
Abdominal Pain	4	4
Erosion	3	3
Injury	3	3
Seizures	3	3
Skin Discoloration	3	3
Post Operative Wound Infection	3	3
Fluid Discharge	2	2
Internal Organ Perforation	2	2
Rash	2	2
Burn(s)	2	2
Death	2	2
Purulent Discharge	2	2
Inflammation	2	2
Granuloma	2	2
Hematoma	1	1
Fever	1	1
Necrosis	1	1
Hypersensitivity/Allergic reaction	1	1
Emotional Changes	1	1
Infarction, Cerebral	1	1
Bradycardia	1	1
Bacterial Infection	1	1
Local Reaction	1	1
Pocket Erosion	1	1
Skin Irritation	1	1
Sepsis	1	1
Skin Inflammation	1	1
Perforation of Vessels	1	1
Therapeutic Response, Decreased	1	1
Discomfort	1	1
Organ Dehiscence	1	1
Sleep Dysfunction	1	1
Abdominal Cramps	1	1
Abdominal Distention	1	1
Unspecified Blood or Lymphatic problem	1	1
Gastrointestinal Hemorrhage	1	1
Melena	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Increased Sensitivity	1	1
Skin Inflammation/ Irritation	1	1