TPLC - Total Product Life Cycle

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Device	lithotriptor, ultrasonic
Regulation Description	Electrohydraulic lithotriptor.
Product Code	FEO
Regulation Number	876.4480
Device Class	2

Premarket Reviews
Manufacturer	Decision
E.M.S ELECTRO MEDICAL SYSTEMS S.A
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	176	176
Output Problem	80	80
Communication or Transmission Problem	77	77
Activation Problem	47	47
Power Problem	38	38
Failure to Power Up	37	37
Energy Output Problem	36	36
No Device Output	34	34
Connection Problem	31	31
Activation Failure	30	30
Defective Device	28	28
Electrical /Electronic Property Problem	20	20
Crack	15	15
Degraded	13	13
Corroded	13	13
Material Twisted/Bent	13	13
Defective Component	13	13
Loss of Power	12	12
Failure to Deliver Energy	10	10
Leak/Splash	10	10
Suction Problem	10	10
Material Deformation	10	10
Loose or Intermittent Connection	9	9
Material Integrity Problem	9	9
Mechanical Problem	9	9
Detachment of Device or Device Component	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Insufficient Device Problem Information	6	7
Overheating of Device	6	6
Suction Failure	6	6
Physical Resistance/Sticking	6	6
Material Split, Cut or Torn	6	6
Protective Measures Problem	6	6
Intermittent Loss of Power	5	5
Thermal Decomposition of Device	5	5
Melted	5	5
No Apparent Adverse Event	5	5
Activation, Positioning or Separation Problem	5	5
Key or Button Unresponsive/not Working	5	5
Self-Activation or Keying	4	4
Image Display Error/Artifact	4	4
Unexpected Shutdown	4	4
Failure to Clean Adequately	4	4
Fracture	4	4
Use of Device Problem	4	4
Device Remains Activated	4	4
Display or Visual Feedback Problem	4	4
Complete Loss of Power	3	3
Naturally Worn	3	3
Excessive Heating	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	816	817
No Patient Involvement	29	29
Insufficient Information	18	18
No Consequences Or Impact To Patient	9	9
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Numbness	1	2
Full thickness (Third Degree) Burn	1	1
Unspecified Respiratory Problem	1	1
Fever	1	1
Fistula	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Internal Organ Perforation	1	1
Pain	1	2
Pneumothorax	1	1
Sepsis	1	1
Urinary Tract Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Olympus Corporation of the Americas	II	Mar-05-2026
2	Olympus Corporation of the Americas	II	Feb-27-2026
3	Olympus Corporation of the Americas	II	Nov-07-2025
4	Olympus Corporation of the Americas	II	Aug-11-2022