TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
CYBERSONICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
E.M.S ELECTRO MEDICAL SYSTEMS SA
	SUBSTANTIALLY EQUIVALENT	1
EMS ELECTRO MEDICAL SYSTEMS SA
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	110	110
Defective Device	60	60
Output Problem	56	56
Communication or Transmission Problem	26	26
Defective Component	22	22
Activation Problem	17	17
Connection Problem	14	14
Power Problem	12	12
No Device Output	10	10
Electrical /Electronic Property Problem	9	9
Energy Output Problem	9	9
Failure to Power Up	9	9
Material Integrity Problem	8	8
Material Twisted/Bent	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Crack	6	6
Suction Problem	6	6
Protective Measures Problem	6	6
Leak/Splash	6	6
Activation Failure	6	6
Loss of Power	5	5
Device Remains Activated	5	5
Fracture	5	5
Intermittent Loss of Power	4	4
Fluid/Blood Leak	4	4
Material Fragmentation	4	4
Detachment of Device or Device Component	4	4
Material Separation	4	4
Loose or Intermittent Connection	3	3
Image Display Error/Artifact	3	3
Device Damaged Prior to Use	3	3
Corroded	3	3
Self-Activation or Keying	3	3
Failure to Deliver Energy	3	3
Difficult to Remove	3	3
Use of Device Problem	3	3
Thermal Decomposition of Device	3	3
Flaked	2	2
Application Program Problem: Power Calculation Error	2	2
Device Reprocessing Problem	2	2
Temperature Problem	2	2
Metal Shedding Debris	2	2
Delivered as Unsterile Product	2	2
Key or Button Unresponsive/not Working	2	2
Device Fell	2	2
Insufficient Information	2	2
Suction Failure	2	2
Intermittent Energy Output	2	2
Electrical Power Problem	2	2
Mechanical Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	224	224
No Patient Involvement	110	110
No Consequences Or Impact To Patient	69	69
No Known Impact Or Consequence To Patient	19	19
No Code Available	12	12
Foreign Body In Patient	3	3
Insufficient Information	2	2
Patient Problem/Medical Problem	1	1
Pneumothorax	1	1
Sepsis	1	1
Inflammation	1	1
Burn, Thermal	1	1
Burn(s)	1	1
Fever	1	1
Injury	1	1
Numbness	1	1
Pain	1	1
Unspecified Respiratory Problem	1	1
Hemorrhage/Bleeding	1	1
Internal Organ Perforation	1	1
Full thickness (Third Degree) Burn	1	1
Fistula	1	1
Urinary Tract Infection	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Olympus Corporation of the Americas	II	Aug-11-2022
2	Olympus Corporation of the Americas	II	Jun-01-2020