TPLC - Total Product Life Cycle

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Device	enteroscope and accessories
Regulation Description	Endoscope and accessories.
Definition	To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product Code	FDA
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
ASPERO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
BODDINGTONS PLASTICS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
FUJIFILM CORPORATON
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	204	204
Failure to Clean Adequately	145	145
Microbial Contamination of Device	41	41
Device Reprocessing Problem	26	26
No Display/Image	17	17
Contamination	15	15
Erratic or Intermittent Display	13	13
Premature Separation	12	12
Poor Quality Image	12	12
Loss of or Failure to Bond	11	11
Corroded	9	9
Pressure Problem	8	8
Melted	8	8
Detachment of Device or Device Component	6	6
Residue After Decontamination	6	6
Use of Incorrect Control/Treatment Settings	6	6
Thermal Decomposition of Device	6	6
Crack	6	6
Insufficient Information	6	6
Break	5	5
Overheating of Device	5	5
Mechanical Problem	5	5
Flare or Flash	5	5
Inflation Problem	5	5
Material Integrity Problem	4	4
Fluid/Blood Leak	3	3
Leak/Splash	3	3
Contamination /Decontamination Problem	3	3
Complete Blockage	3	3
Failure to Deflate	2	2
Communication or Transmission Problem	2	2
Failure to Calibrate	2	2
Increase in Pressure	2	2
Device Contamination with Chemical or Other Material	2	2
Device Sensing Problem	2	2
Partial Blockage	2	2
Misassembly by Users	2	2
Optical Problem	2	2
Material Deformation	2	2
Structural Problem	2	2
Obstruction of Flow	2	2
Use of Device Problem	2	2
Device Handling Problem	1	1
Material Separation	1	1
Decrease in Pressure	1	1
Positioning Problem	1	1
Material Twisted/Bent	1	1
Improper Flow or Infusion	1	1
Material Protrusion/Extrusion	1	1
Activation Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	349	349
Perforation	58	58
Pancreatitis	51	51
Hemorrhage/Bleeding	33	33
Bowel Perforation	31	31
Inflammation	30	30
No Code Available	20	20
Abdominal Pain	16	16
Laceration(s)	15	15
Unspecified Hepatic or Biliary Problem	14	14
Injury	14	14
Abscess	8	8
No Patient Involvement	8	8
Bradycardia	7	7
Laceration(s) of Esophagus	7	7
Hypoxia	6	6
Abrasion	6	6
Aspiration Pneumonitis	5	5
Cancer	5	5
No Consequences Or Impact To Patient	5	5
Unspecified Tissue Injury	5	5
Fever	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Pneumonia	4	4
Gastrointestinal Hemorrhage	4	4
Hyperglycemia	4	4
No Known Impact Or Consequence To Patient	4	4
Peritonitis	4	4
Respiratory Failure	3	3
Pain	3	3
Rupture	3	3
Ischemia	3	3
Unspecified Gastrointestinal Problem	3	3
Abdominal Distention	2	2
Insufficient Information	2	2
Dyspnea	2	2
Nausea	2	2
Death	2	2
Organ Dehiscence	2	2
Melena	2	2
High Blood Pressure/ Hypertension	2	2
Pulmonary Embolism	2	2
Air Embolism	2	2
Dyskinesia	1	1
Chills	1	1
Foreign Body In Patient	1	1
Stomach Ulceration	1	1
Erythema	1	1
Skin Inflammation/ Irritation	1	1
Diabetic Ketoacidosis	1	1