TPLC - Total Product Life Cycle

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Device	pump, air, non-manual, for endoscope
Regulation Description	Endoscope and accessories.
Product Code	FEQ
Regulation Number	876.1500
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Pumping Problem	230	230
Break	130	130
Key or Button Unresponsive/not Working	125	125
Leak/Splash	92	92
Infusion or Flow Problem	81	81
Failure to Pump	69	69
Improper Flow or Infusion	38	38
Insufficient Flow or Under Infusion	33	33
Crack	32	32
Mechanical Problem	31	31
Loose or Intermittent Connection	24	24
Free or Unrestricted Flow	21	21
Pressure Problem	20	20
Electrical /Electronic Property Problem	20	20
Connection Problem	20	20
Excess Flow or Over-Infusion	20	20
Detachment of Device or Device Component	19	19
Flushing Problem	18	18
Fluid/Blood Leak	17	17
Output Problem	16	16
No Device Output	14	14
Gas/Air Leak	13	13
Defective Component	13	13
Intermittent Loss of Power	10	10
No Flow	10	10
Degraded	10	10
Failure to Power Up	9	9
Backflow	9	9
Material Integrity Problem	8	8
Decreased Pump Speed	8	8
Reflux within Device	8	8
Disconnection	8	8
Defective Device	7	7
Adverse Event Without Identified Device or Use Problem	6	6
Activation Failure	6	6
Power Problem	6	6
Activation Problem	6	6
Naturally Worn	6	6
Pumping Stopped	5	5
Use of Device Problem	5	5
Material Split, Cut or Torn	5	5
Intermittent Infusion	4	4
Inaccurate Flow Rate	4	4
Circuit Failure	4	4
No Display/Image	4	4
Energy Output Problem	4	4
Moisture Damage	3	3
Contamination	3	3
Decrease in Pressure	3	3
Communication or Transmission Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1176	1176
Insufficient Information	10	10
Hemorrhage/Bleeding	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Bowel Perforation	2	2
Perforation	2	2
Fall	2	2
Laceration(s)	2	2
Abdominal Pain	1	1
Patient Problem/Medical Problem	1	1
Gastrointestinal Hemorrhage	1	1
No Known Impact Or Consequence To Patient	1	1
Injury	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Skin Tears	1	1
Low Oxygen Saturation	1	1
Excessive Tear Production	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Erbe Medical, LLC	II	May-01-2026
2	Olympus Corporation of the Americas	II	Oct-25-2024