TPLC - Total Product Life Cycle

• Device: scaler, ultrasonic
• Product Code: ELC
• Regulation Number: 872.4850
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
E.M.S ELECTRO MEDICAL SYSTEMS S.A
	SUBSTANTIALLY EQUIVALENT	1
E.M.S ELECTRO MEDICAL SYSTEMS S.A.
	SUBSTANTIALLY EQUIVALENT	1
ENGINEERED ENDODONTICS
	SUBSTANTIALLY EQUIVALENT	1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRON CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SCHLUMBOHM GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
SONENDO, INC
	SUBSTANTIALLY EQUIVALENT	1
SONENDO, INC.
	SUBSTANTIALLY EQUIVALENT	1
TTBIO CORP.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2018	289	289
2019	302	302
2020	164	164
2021	166	166
2022	165	165
2023	37	37

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	501	501
Break	413	413
Restricted Flow rate	275	275
Temperature Problem	69	69
No Flow	30	30
Infusion or Flow Problem	19	19
Improper Flow or Infusion	11	11
Material Fragmentation	10	10
Device Operates Differently Than Expected	8	8
Device Emits Odor	7	7
Insufficient Information	7	7
Fluid/Blood Leak	7	7
Insufficient Flow or Under Infusion	7	7
Unintended Electrical Shock	6	6
Component Missing	5	5
Excessive Heating	4	4
Noise, Audible	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Power Problem	3	3
Detachment of Device or Device Component	3	3
Patient-Device Incompatibility	3	3
Therapeutic or Diagnostic Output Failure	3	3
Defective Device	3	3
Mechanical Problem	3	3
Fracture	3	3
Detachment Of Device Component	3	3
Inaccurate Flow Rate	2	2
Leak/Splash	2	2
Loose or Intermittent Connection	2	2
Melted	2	2
Decrease in Pressure	2	2
Difficult to Remove	2	2
Sparking	2	2
Defective Component	2	2
Smoking	2	2
Appropriate Term/Code Not Available	2	2
Ejection Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Integrity Problem	2	2
Moisture or Humidity Problem	2	2
Naturally Worn	1	1
Device Dislodged or Dislocated	1	1
Free or Unrestricted Flow	1	1
Output Problem	1	1
Material Twisted/Bent	1	1
Blocked Connection	1	1
Device Handling Problem	1	1
Activation Problem	1	1
Separation Problem	1	1
Device Stops Intermittently	1	1
Vibration	1	1
Obstruction of Flow	1	1
Material Separation	1	1
Product Quality Problem	1	1
Failure to Power Up	1	1
Device Maintenance Issue	1	1
Difficult to Insert	1	1
Intermittent Continuity	1	1
Corroded	1	1
Electrical /Electronic Property Problem	1	1
Thermal Decomposition of Device	1	1
Complete Blockage	1	1
Alarm Not Visible	1	1
Bent	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	615	615
No Clinical Signs, Symptoms or Conditions	390	390
No Known Impact Or Consequence To Patient	128	128
Insufficient Information	62	62
No Information	48	48
Foreign Body In Patient	16	16
Device Embedded In Tissue or Plaque	13	13
Burn(s)	8	8
Pain	6	6
Injury	4	4
Swelling	4	4
Burn, Thermal	4	4
Needle Stick/Puncture	3	3
Numbness	3	3
Tinnitus	2	2
Hemorrhage/Bleeding	2	2
No Code Available	2	2
No Patient Involvement	2	2
Patient Problem/Medical Problem	2	2
Bowel Perforation	1	1
Fluid Discharge	1	1
Electric Shock	1	1
Skin Burning Sensation	1	1
Unspecified Tissue Injury	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Laceration(s)	1	1
Undesired Nerve Stimulation	1	1
Skin Discoloration	1	1
Dyspnea	1	1
Airway Obstruction	1	1
Exposure to Body Fluids	1	1
Tissue Damage	1	1
Dysphasia	1	1
Sensitivity of Teeth	1	1
Sinus Perforation	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Sonendo Inc	II	Nov-14-2022
2	Sonendo Inc	II	May-28-2020