TPLC - Total Product Life Cycle

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Device	insufflator, automatic carbon-dioxide for endoscope
Regulation Description	Endoscope and accessories.
Product Code	FCX
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
IDE VISION, LTD.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
PALLIARE , LTD.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	62	62
Defective Component	36	36
Gas Output Problem	29	29
Pressure Problem	27	27
No Apparent Adverse Event	26	26
Electrical /Electronic Property Problem	21	21
Output Problem	21	21
Unexpected Shutdown	20	20
Pumping Stopped	14	14
Device Alarm System	12	12
Device Handling Problem	11	11
Adverse Event Without Identified Device or Use Problem	11	11
Use of Device Problem	7	7
Intermittent Loss of Power	6	6
Mechanical Problem	6	6
Gas/Air Leak	6	6
Device Reprocessing Problem	5	5
Improper Flow or Infusion	5	5
Display or Visual Feedback Problem	4	4
Detachment of Device or Device Component	4	4
Infusion or Flow Problem	4	4
No Display/Image	3	3
Failure of Device to Self-Test	3	3
Failure to Power Up	3	3
Noise, Audible	2	2
No Flow	2	2
Complete Loss of Power	2	2
Incorrect Interpretation of Signal	2	2
Power Problem	2	2
Medical Gas Supply Problem	2	2
Explosion	2	2
Environmental Particulates	2	2
Optical Problem	2	2
Insufficient Flow or Under Infusion	2	2
Decrease in Pressure	2	2
Obstruction of Flow	2	2
Unintended Application Program Shut Down	2	2
Activation Problem	2	2
Leak/Splash	2	2
Inaccurate Flow Rate	1	1
Misassembly During Maintenance/Repair	1	1
Use of Incorrect Control/Treatment Settings	1	1
Material Rupture	1	1
Inappropriate Tactile Prompt/Feedback	1	1
Failure to Align	1	1
Product Quality Problem	1	1
Operating System Version or Upgrade Problem	1	1
Contamination /Decontamination Problem	1	1
Low Audible Alarm	1	1
Failure to Conduct	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	217	217
Insufficient Information	47	47
Bradycardia	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Perforation	2	2
Cardiac Arrest	2	2
Foreign Body In Patient	2	2
No Consequences Or Impact To Patient	2	2
Air Embolism	1	1
Abdominal Pain	1	1
Electric Shock	1	1
Intra-Abdominal Hemorrhage	1	1
Arrhythmia	1	1
Bowel Perforation	1	1
Inflammation	1	1
Bowel Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Northgate Technologies, Inc.	II	Feb-24-2021