TPLC - Total Product Life Cycle

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Device	pump, air, non-manual, for endoscope
Product Code	FEQ
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
BYRNE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENDOCHOICE, INC.
	SUBSTANTIALLY EQUIVALENT	6
ERBE USA, INC.
	SUBSTANTIALLY EQUIVALENT	3
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
	SUBSTANTIALLY EQUIVALENT	1
KEYMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATE ENDOSCOPY GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES ENDOSCOPY GROUP, INC
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES ENDOSCOPY GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	78	78
Pumping Problem	76	76
Key or Button Unresponsive/not Working	72	72
Failure to Pump	50	50
Insufficient Flow or Under Infusion	26	26
Infusion or Flow Problem	20	20
Mechanical Problem	19	19
Free or Unrestricted Flow	14	14
Improper Flow or Infusion	13	13
Crack	13	13
Pressure Problem	13	13
Reflux within Device	13	13
Leak/Splash	11	11
No Device Output	8	8
Fluid/Blood Leak	8	8
Loose or Intermittent Connection	7	7
Detachment of Device or Device Component	7	7
Decreased Pump Speed	6	6
Defective Device	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Defective Component	5	5
Output Problem	5	5
Activation Problem	5	5
Intermittent Loss of Power	4	4
No Flow	4	4
Electrical /Electronic Property Problem	4	4
Energy Output Problem	4	4
Flushing Problem	4	4
Appropriate Term/Code Not Available	4	4
Excess Flow or Over-Infusion	4	4
Gas/Air Leak	4	4
Pumping Stopped	3	3
Power Problem	3	3
Increase in Pressure	3	3
Connection Problem	3	3
Naturally Worn	3	3
Calibration Problem	3	3
Material Integrity Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Backflow	3	3
Inaccurate Flow Rate	2	2
Decrease in Pressure	2	2
Use of Device Problem	2	2
Intermittent Infusion	2	2
No Display/Image	2	2
Degraded	2	2
Communication or Transmission Problem	2	2
Failure to Power Up	2	2
Failure to Prime	2	2
Circuit Failure	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	484	484
No Known Impact Or Consequence To Patient	18	18
No Consequences Or Impact To Patient	12	12
Hemorrhage/Bleeding	10	10
Insufficient Information	7	7
Bowel Perforation	2	2
Perforation	2	2
Swelling	2	2
Fall	2	2
Laceration(s)	2	2
Abdominal Pain	1	1
Patient Problem/Medical Problem	1	1
Blood Loss	1	1
Injury	1	1
Exposure to Body Fluids	1	1
No Patient Involvement	1	1
Swelling/ Edema	1	1
Skin Tears	1	1
Excessive Tear Production	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Olympus America Inc.	II	Nov-15-2013
2	Olympus America Inc.	III	Jan-18-2012
3	Olympus Corporation of the Americas	II	Oct-08-2015