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	231	231
Break	131	131
Key or Button Unresponsive/not Working	125	125
Leak/Splash	104	104
Infusion or Flow Problem	82	82
Failure to Pump	71	71
Improper Flow or Infusion	40	40
Insufficient Flow or Under Infusion	35	35
Crack	32	32
Mechanical Problem	31	31
Excess Flow or Over-Infusion	23	23
Loose or Intermittent Connection	23	23
Connection Problem	21	21
Free or Unrestricted Flow	21	21
Electrical /Electronic Property Problem	20	20
Flushing Problem	19	19
Detachment of Device or Device Component	19	19
Pressure Problem	18	18
Gas/Air Leak	15	15
Output Problem	15	15
No Device Output	14	14
Fluid/Blood Leak	14	14
Defective Component	12	12
Degraded	10	10
Intermittent Loss of Power	10	10
Failure to Power Up	9	9
Backflow	9	9
Material Integrity Problem	8	8
Decreased Pump Speed	8	8
No Flow	8	8
Disconnection	8	8
Reflux within Device	7	7
Defective Device	6	6
Failure to Clean Adequately	6	6
Contamination	6	6
Contamination /Decontamination Problem	6	6
Activation Problem	6	6
Naturally Worn	6	6
Activation Failure	6	6
Power Problem	6	6
Pumping Stopped	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Intermittent Infusion	5	5
Inaccurate Flow Rate	5	5
Material Split, Cut or Torn	5	5
Decrease in Pressure	4	4
Use of Device Problem	4	4
No Display/Image	4	4
Circuit Failure	4	4
Moisture Damage	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1230	1230
Insufficient Information	10	10
Hemorrhage/Blood Loss/Bleeding	10	10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Bowel Perforation	2	2
Fall	2	2
Laceration(s)	2	2
Low Oxygen Saturation	2	2
Gastrointestinal Hemorrhage	1	1
Perforation	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	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