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	25	25
Reflux within Device	12	12
Pumping Problem	11	11
Pressure Problem	10	10
Insufficient Flow or Under Infusion	7	7
Adverse Event Without Identified Device or Use Problem	6	6
Key or Button Unresponsive/not Working	6	6
Detachment of Device or Device Component	5	5
Fluid/Blood Leak	5	5
Energy Output Problem	4	4
Crack	4	4
Free or Unrestricted Flow	4	4
Failure to Pump	4	4
Appropriate Term/Code Not Available	4	4
No Flow	3	3
Improper Flow or Infusion	3	3
Calibration Problem	3	3
Increase in Pressure	3	3
Backflow	3	3
Decreased Pump Speed	3	3
Failure to Prime	2	2
Excess Flow or Over-Infusion	2	2
Leak/Splash	2	2
Loose or Intermittent Connection	2	2
Defective Device	2	2
Gas/Air Leak	2	2
Use of Device Problem	2	2
Infusion or Flow Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Activation Problem	2	2
Therapeutic or Diagnostic Output Failure	1	1
Protective Measures Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Twisted/Bent	1	1
Naturally Worn	1	1
Optical Obstruction	1	1
Output Problem	1	1
Positioning Problem	1	1
Power Problem	1	1
Self-Activation or Keying	1	1
Device Inoperable	1	1
Device Contamination with Body Fluid	1	1
Intermittent Infusion	1	1
Failure to Calibrate	1	1
Structural Problem	1	1
Device Operates Differently Than Expected	1	1
Difficult to Open or Close	1	1
Device Displays Incorrect Message	1	1
Communication or Transmission Problem	1	1
Mechanical Problem	1	1
Degraded	1	1
No Display/Image	1	1
Contamination	1	1
No Device Output	1	1
Decrease in Pressure	1	1
Flushing Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	101	101
No Known Impact Or Consequence To Patient	18	18
No Consequences Or Impact To Patient	12	12
Hemorrhage/Bleeding	10	10
Insufficient Information	3	3
Fall	2	2
Bowel Perforation	2	2
Laceration(s)	2	2
Perforation	2	2
Swelling	2	2
Excessive Tear Production	1	1
Injury	1	1
Skin Tears	1	1
Blood Loss	1	1
No Patient Involvement	1	1
Patient Problem/Medical Problem	1	1
Abdominal Pain	1	1
Exposure to Body Fluids	1	1
Swelling/ Edema	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