TPLC - Total Product Life Cycle

show TPLC since

Device	insufflator, automatic carbon-dioxide for endoscope
Product Code	FCX
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
BARONOVA, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	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	25	25
Pressure Problem	20	20
No Apparent Adverse Event	15	15
Pumping Stopped	14	14
Device Alarm System	11	11
Device Handling Problem	11	11
Infusion or Flow Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Device Reprocessing Problem	4	4
Defective Component	3	3
Obstruction of Flow	2	2
No Display/Image	2	2
Use of Device Problem	2	2
Noise, Audible	2	2
Patient Device Interaction Problem	2	2
Complete Loss of Power	2	2
Unexpected Shutdown	2	2
Activation Problem	2	2
Failure to Clean Adequately	1	1
Unintended Electrical Shock	1	1
Explosion	1	1
Therapeutic or Diagnostic Output Failure	1	1
Low Audible Alarm	1	1
Break	1	1
Gas Output Problem	1	1
Inflation Problem	1	1
Leak/Splash	1	1
Failure to Power Up	1	1
Use of Incorrect Control/Treatment Settings	1	1
Crack	1	1
Deflation Problem	1	1
Malposition of Device	1	1
Contamination /Decontamination Problem	1	1
Improper Flow or Infusion	1	1
Product Quality Problem	1	1
Material Rupture	1	1
Sensing Intermittently	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	72	72
Insufficient Information	22	22
Bradycardia	4	4
Bowel Perforation	3	3
Cardiac Arrest	2	2
Abdominal Pain	2	2
Perforation	2	2
No Consequences Or Impact To Patient	2	2
Discomfort	1	1
Electric Shock	1	1
Air Embolism	1	1
Bowel Burn	1	1
Hemorrhage/Bleeding	1	1
Inflammation	1	1
No Known Impact Or Consequence To Patient	1	1

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