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
BRACCO DIAGNOSTIC, INC.
	SUBSTANTIALLY EQUIVALENT	3
BYRNE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
LEXION MEDICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	1
NEXCORE TECHNOLOGY, LLC
	SUBSTANTIALLY EQUIVALENT	1
PALLIARE LTD.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	29	29
Pressure Problem	20	20
No Apparent Adverse Event	15	15
Pumping Stopped	14	14
Device Handling Problem	12	12
Device Alarm System	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Burst Container or Vessel	5	5
Device Reprocessing Problem	4	4
Infusion or Flow Problem	4	4
Air Leak	3	3
Noise, Audible	3	3
Material Rupture	3	3
Defective Component	3	3
Inflation Problem	3	3
Deflation Problem	2	2
No Display/Image	2	2
Obstruction of Flow	2	2
Malposition of Device	2	2
Device Inoperable	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	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
Sensing Intermittently	1	1
Contamination /Decontamination Problem	1	1
Extrusion	1	1
Improper Flow or Infusion	1	1
Inaccurate Flow Rate	1	1
Gas Output Problem	1	1
Intermittent Continuity	1	1
Use of Incorrect Control/Treatment Settings	1	1
Crack	1	1
Difficult to Insert	1	1
Leak/Splash	1	1
Misconnection	1	1
Loss of Power	1	1
Failure to Power Up	1	1
Low Audible Alarm	1	1
Break	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	73	73
Insufficient Information	22	22
Abdominal Pain	8	8
No Consequences Or Impact To Patient	7	7
Bowel Perforation	7	7
Bradycardia	5	5
No Known Impact Or Consequence To Patient	4	4
Perforation	3	3
Hemorrhage/Bleeding	2	2
Inflammation	2	2
Cardiac Arrest	2	2
No Information	2	2
Air Embolism	2	2
No Code Available	1	1
Test Result	1	1
Peritonitis	1	1
Discomfort	1	1
Perforation of Esophagus	1	1
Reaction	1	1
Electric Shock	1	1
Abdominal Distention	1	1
Death	1	1
Embolism	1	1
Fever	1	1
Bowel Burn	1	1
Abscess	1	1
Pain	1	1
Low Blood Pressure/ Hypotension	1	1
Respiratory Distress	1	1
Therapeutic Effects, Unexpected	1	1
Tissue Damage	1	1
Vomiting	1	1