TPLC - Total Product Life Cycle

show TPLC since

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
Display or Visual Feedback Problem	7	7
Use of Device Problem	7	7
Inflation Problem	7	7
Intermittent Loss of Power	6	6
Mechanical Problem	6	6
Improper Flow or Infusion	6	6
Device Reprocessing Problem	5	5
Complete Loss of Power	5	5
Circuit Failure	4	4
Detachment of Device or Device Component	4	4
Power Problem	3	3
Failure of Device to Self-Test	3	3
Activation Problem	3	3
Insufficient Flow or Under Infusion	3	3
Infusion or Flow Problem	3	3
Failure to Power Up	3	3
No Display/Image	3	3
Decrease in Pressure	3	3
Medical Gas Supply Problem	2	2
Failure to Align	2	2
Explosion	2	2
Incorrect Interpretation of Signal	2	2
Unintended Application Program Shut Down	2	2
Noise, Audible	2	2
Obstruction of Flow	2	2
Poor Quality Image	2	2
No Flow	2	2
No Device Output	2	2
Environmental Particulates	2	2
Optical Problem	2	2
Leak/Splash	2	2
Product Quality Problem	1	1
Misassembly During Maintenance/Repair	1	1
Unintended System Motion	1	1
Application Program Problem	1	1
Failure to Sense	1	1
Incorrect, Inadequate or Imprecise Result or Readings	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
Bowel Perforation	1	1
Arrhythmia	1	1
Inflammation	1	1
Abdominal Pain	1	1

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