TPLC - Total Product Life Cycle

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Device	enteroscope 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	1
BODDINGTONS PLASTICS LTD
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
FUJIFILM CORPORATON
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	197	197
Failure to Clean Adequately	71	71
Appropriate Term/Code Not Available	43	43
Microbial Contamination of Device	36	36
Insufficient Information	33	33
Contamination	13	13
Device Operates Differently Than Expected	10	10
Device Reprocessing Problem	9	9
Mechanical Problem	7	7
Inflation Problem	7	7
Break	5	5
Crack	5	5
Pressure Problem	4	4
Corroded	4	4
Use of Device Problem	4	4
Leak/Splash	3	3
Patient-Device Incompatibility	3	3
Contamination /Decontamination Problem	3	3
Misconnection	3	3
Fluid/Blood Leak	2	2
Failure to Deflate	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
Structural Problem	2	2
Obstruction of Flow	2	2
Deflation Problem	2	2
Complete Blockage	2	2
Device Handling Problem	1	1
Physical Resistance	1	1
Difficult To Position	1	1
Residue After Decontamination	1	1
Material Protrusion/Extrusion	1	1
No Apparent Adverse Event	1	1
Explosion	1	1
Overfill	1	1
Output above Specifications	1	1
Protective Measures Problem	1	1
No Audible Alarm	1	1
Positioning Problem	1	1
Connection Problem	1	1
Failure of Device to Self-Test	1	1
Overheating of Device	1	1
Output Problem	1	1
Display or Visual Feedback Problem	1	1
Improper or Incorrect Procedure or Method	1	1
No Flow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	133	133
Perforation	92	92
Inflammation	62	62
Pancreatitis	39	39
No Code Available	38	38
Hemorrhage/Bleeding	30	30
Not Applicable	28	28
Bowel Perforation	22	22
Pneumonia	20	20
Injury	18	18
Laceration(s)	16	16
Unspecified Hepatic or Biliary Problem	14	14
No Consequences Or Impact To Patient	13	13
Abdominal Pain	12	12
No Patient Involvement	11	11
Unspecified Infection	10	10
No Known Impact Or Consequence To Patient	8	8
Bradycardia	7	7
Laceration(s) of Esophagus	7	7
Hypoxia	6	6
Ischemia	6	6
Abscess	6	6
Abrasion	6	6
Aspiration Pneumonitis	5	5
Cancer	5	5
Unspecified Tissue Injury	5	5
Blood Loss	5	5
Peritonitis	4	4
Fever	4	4
Respiratory Failure	3	3
Internal Organ Perforation	3	3
Death	3	3
Pulmonary Embolism	2	2
Organ Dehiscence	2	2
Pain	2	2
Hyperglycemia	2	2
Dyspnea	2	2
Insufficient Information	2	2
Abdominal Distention	2	2
Aspiration/Inhalation	2	2
Gastrointestinal Hemorrhage	2	2
Nausea	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Melena	2	2
High Blood Pressure/ Hypertension	2	2
Air Embolism	2	2
Flatus	1	1
Stomach Ulceration	1	1
Irritation	1	1
Unspecified Kidney or Urinary Problem	1	1