TPLC - Total Product Life Cycle

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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	21	21
No Apparent Adverse Event	15	15
Pumping Stopped	14	14
Device Handling Problem	12	12
Adverse Event Without Identified Device or Use Problem	12	12
Device Alarm System	11	11
Burst Container or Vessel	5	5
Device Reprocessing Problem	4	4
Infusion or Flow Problem	4	4
Noise, Audible	3	3
Inflation Problem	3	3
Material Rupture	3	3
Defective Component	3	3
Air Leak	3	3
Gas Output Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Device Inoperable	2	2
Complete Loss of Power	2	2
Obstruction of Flow	2	2
Use of Device Problem	2	2
Patient Device Interaction Problem	2	2
Deflation Problem	2	2
Activation Problem	2	2
Malposition of Device	2	2
No Display/Image	2	2
Output Problem	2	2
Unexpected Shutdown	2	2
Contamination /Decontamination Problem	1	1
Difficult to Insert	1	1
Gas/Air Leak	1	1
Failure to Power Up	1	1
Improper Flow or Infusion	1	1
Therapeutic or Diagnostic Output Failure	1	1
Failure to Clean Adequately	1	1
Crack	1	1
Insufficient Flow or Under Infusion	1	1
Inaccurate Flow Rate	1	1
Unintended Electrical Shock	1	1
Break	1	1
Misconnection	1	1
Use of Incorrect Control/Treatment Settings	1	1
Environmental Particulates	1	1
Explosion	1	1
Product Quality Problem	1	1
Low Audible Alarm	1	1
Power Problem	1	1
Sensing Intermittently	1	1
Intermittent Continuity	1	1
Leak/Splash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	77	77
Insufficient Information	25	25
Abdominal Pain	8	8
Bowel Perforation	7	7
No Consequences Or Impact To Patient	7	7
Bradycardia	5	5
No Known Impact Or Consequence To Patient	4	4
Perforation	3	3
Air Embolism	2	2
No Information	2	2
Inflammation	2	2
Cardiac Arrest	2	2
Hemorrhage/Bleeding	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Death	1	1
Electric Shock	1	1
Respiratory Distress	1	1
No Code Available	1	1
Test Result	1	1
Perforation of Esophagus	1	1
Abdominal Distention	1	1
Bowel Burn	1	1
Peritonitis	1	1
Fever	1	1
Vomiting	1	1
Discomfort	1	1
Pain	1	1
Reaction	1	1
Abscess	1	1
Tissue Damage	1	1
Embolism	1	1
Therapeutic Effects, Unexpected	1	1
Low Blood Pressure/ Hypotension	1	1