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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Device Problem Information	69	69
Defective Component	45	45
No Apparent Adverse Event	42	42
Gas Output Problem	37	37
Output Problem	34	34
Pressure Problem	30	30
Electrical /Electronic Property Problem	27	27
Unexpected Shutdown	25	25
Pumping Stopped	14	14
Adverse Event Without Identified Device or Use Problem	12	12
Device Handling Problem	12	12
Device Alarm System	12	12
Gas/Air Leak	9	9
Use of Device Problem	7	7
Inflation Problem	7	7
Display or Visual Feedback Problem	7	7
Mechanical Problem	6	6
Improper Flow or Infusion	6	6
Intermittent Loss of Power	6	6
Device Reprocessing Problem	5	5
Complete Loss of Power	5	5
Detachment of Device or Device Component	4	4
Circuit Failure	4	4
Insufficient Flow or Under Infusion	3	3
Decrease in Pressure	3	3
Failure to Power Up	3	3
Activation Problem	3	3
Failure of Device to Self-Test	3	3
Infusion or Flow Problem	3	3
Power Problem	3	3
No Display/Image	3	3
Incorrect Interpretation of Signal	2	2
No Device Output	2	2
Poor Quality Image	2	2
Leak/Splash	2	2
Unintended Application Program Shut Down	2	2
Explosion	2	2
Obstruction of Flow	2	2
Noise, Audible	2	2
Failure to Align	2	2
Optical Problem	2	2
No Flow	2	2
Medical Gas Supply Problem	2	2
Environmental Particulates	2	2
Failure to Sense	1	1
Sensing Intermittently	1	1
Material Rupture	1	1
Failure to Analyze Signal	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	268	268
Insufficient Information	57	57
Bradycardia	7	7
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	6	6
No Consequences Or Impact To Patient	2	2
Cardiac Arrest	2	2
Burn(s)	2	2
Perforation	2	2
Foreign Body In Patient	2	2
Electric Shock	1	1
Bowel Burn	1	1
Intra-Abdominal Hemorrhage	1	1
Inflammation	1	1
Abdominal Pain	1	1
Bowel Perforation	1	1
Arrhythmia	1	1

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