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
Pressure Problem	27	27
Gas Output Problem	23	23
Defective Component	22	22
No Apparent Adverse Event	22	22
Electrical /Electronic Property Problem	20	20
Output Problem	20	20
Unexpected Shutdown	19	19
Pumping Stopped	14	14
Device Alarm System	12	12
Device Handling Problem	11	11
Adverse Event Without Identified Device or Use Problem	11	11
Intermittent Loss of Power	6	6
Mechanical Problem	6	6
Gas/Air Leak	6	6
Device Reprocessing Problem	5	5
Use of Device Problem	5	5
Improper Flow or Infusion	5	5
Infusion or Flow Problem	4	4
No Display/Image	3	3
Noise, Audible	2	2
No Flow	2	2
Complete Loss of Power	2	2
Failure of Device to Self-Test	2	2
Incorrect Interpretation of Signal	2	2
Power Problem	2	2
Explosion	2	2
Environmental Particulates	2	2
Detachment of Device or Device Component	2	2
Optical Problem	2	2
Insufficient Flow or Under Infusion	2	2
Decrease in Pressure	2	2
Obstruction of Flow	2	2
Failure to Power Up	2	2
Unintended Application Program Shut Down	2	2
Activation Problem	2	2
Inaccurate Flow Rate	1	1
Inappropriate Tactile Prompt/Feedback	1	1
Failure to Align	1	1
Misassembly During Maintenance/Repair	1	1
Use of Incorrect Control/Treatment Settings	1	1
Material Rupture	1	1
Product Quality Problem	1	1
Operating System Version or Upgrade Problem	1	1
Contamination /Decontamination Problem	1	1
Failure to Clean Adequately	1	1
Low Audible Alarm	1	1
Failure to Conduct	1	1
Medical Gas Supply Problem	1	1
Defective Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	199	199
Insufficient Information	46	46
Bradycardia	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Perforation	2	2
Cardiac Arrest	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