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	1
FUJIFILM CORPORATON
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Clean Adequately	145	145
Adverse Event Without Identified Device or Use Problem	135	135
Microbial Contamination of Device	37	37
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
Crack	6	6
Insufficient Information	6	6
Detachment of Device or Device Component	6	6
Use of Incorrect Control/Treatment Settings	6	6
Thermal Decomposition of Device	6	6
Overheating of Device	5	5
Residue After Decontamination	5	5
Inflation Problem	5	5
Flare or Flash	5	5
Break	5	5
Material Integrity Problem	4	4
Contamination /Decontamination Problem	3	3
Fluid/Blood Leak	3	3
Leak/Splash	3	3
Mechanical 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
No Audible Alarm	1	1
Material Separation	1	1
Positioning Problem	1	1
Deflation Problem	1	1
Output above Specifications	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	52	52
Pancreatitis	51	51
Hemorrhage/Bleeding	33	33
Bowel Perforation	28	28
Abdominal Pain	16	16
Unspecified Hepatic or Biliary Problem	14	14
Laceration(s)	14	14
No Patient Involvement	8	8
Bradycardia	7	7
Laceration(s) of Esophagus	7	7
Hypoxia	6	6
Abrasion	6	6
Aspiration Pneumonitis	5	5
Unspecified Tissue Injury	5	5
Fever	5	5
No Consequences Or Impact To Patient	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Pneumonia	4	4
Gastrointestinal Hemorrhage	4	4
Hyperglycemia	4	4
Inflammation	4	4
Peritonitis	4	4
Respiratory Failure	3	3
Abscess	3	3
Pain	3	3
Injury	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
Melena	2	2
Organ Dehiscence	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
Sepsis	1	1
Unspecified Kidney or Urinary Problem	1	1
Failure to Anastomose	1	1