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 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	190	190
Failure to Clean Adequately	48	48
Appropriate Term/Code Not Available	43	43
Insufficient Information	33	33
Microbial Contamination of Device	32	32
Contamination	13	13
Device Operates Differently Than Expected	10	10
Device Reprocessing Problem	8	8
Inflation Problem	7	7
Mechanical Problem	6	6
Break	5	5
Corroded	4	4
Crack	4	4
Use of Device Problem	4	4
Patient-Device Incompatibility	3	3
Contamination /Decontamination Problem	3	3
Pressure Problem	3	3
Leak/Splash	3	3
Misconnection	3	3
Fluid/Blood Leak	2	2
Deflation Problem	2	2
Complete Blockage	2	2
Partial Blockage	2	2
Device Sensing Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Obstruction of Flow	2	2
Failure to Calibrate	2	2
Increase in Pressure	2	2
Failure to Deflate	2	2
Misassembly by Users	2	2
No Apparent Adverse Event	1	1
Device Handling Problem	1	1
Residue After Decontamination	1	1
Overfill	1	1
Physical Resistance	1	1
Connection Problem	1	1
Material Protrusion/Extrusion	1	1
No Flow	1	1
Failure of Device to Self-Test	1	1
Protective Measures Problem	1	1
Output Problem	1	1
Positioning Problem	1	1
No Audible Alarm	1	1
Detachment Of Device Component	1	1
Display or Visual Feedback Problem	1	1
Output above Specifications	1	1
Overheating of Device	1	1
Difficult To Position	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	99	99
Perforation	88	88
Inflammation	62	62
No Code Available	38	38
Pancreatitis	35	35
Not Applicable	28	28
Hemorrhage/Bleeding	28	28
Pneumonia	20	20
Bowel Perforation	19	19
Injury	18	18
Laceration(s)	14	14
Unspecified Hepatic or Biliary Problem	14	14
No Consequences Or Impact To Patient	13	13
No Patient Involvement	11	11
Unspecified Infection	10	10
Abdominal Pain	10	10
No Known Impact Or Consequence To Patient	8	8
Laceration(s) of Esophagus	7	7
Ischemia	6	6
Abrasion	6	6
Abscess	6	6
Hypoxia	6	6
Bradycardia	5	5
Blood Loss	5	5
Cancer	5	5
Unspecified Tissue Injury	5	5
Aspiration Pneumonitis	3	3
Internal Organ Perforation	3	3
Death	3	3
Dyspnea	2	2
Fever	2	2
Air Embolism	2	2
Aspiration/Inhalation	2	2
Hyperglycemia	2	2
High Blood Pressure/ Hypertension	2	2
Pain	2	2
Nausea	2	2
Peritonitis	2	2
Gastrointestinal Hemorrhage	2	2
Melena	2	2
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Organ Dehiscence	2	2
Abdominal Distention	2	2
Patient Problem/Medical Problem	1	1
Syncope/Fainting	1	1
Unspecified Kidney or Urinary Problem	1	1
Stomach Ulceration	1	1
Unspecified Gastrointestinal Problem	1	1
Stenosis	1	1
Ulcer	1	1
Liver Damage/Dysfunction	1	1
Bronchospasm	1	1
Perforation of Esophagus	1	1
Low Oxygen Saturation	1	1
Respiratory Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Irritation	1	1
Erosion	1	1
Flatus	1	1