TPLC - Total Product Life Cycle

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Device	handpiece, contra- and right-angle attachment, dental
Product Code	EGS
Regulation Number	872.4200
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	554	555
Overheating of Device	429	429
Mechanical Problem	117	117
Temperature Problem	84	84
Output Problem	45	45
Dent in Material	45	45
Therapeutic or Diagnostic Output Failure	43	43
Defective Device	35	35
Physical Resistance/Sticking	33	33
Device Handling Problem	18	18
Loose or Intermittent Connection	15	15
Break	14	14
Failure to Align	11	11
Computer Operating System Problem	10	10
Use of Device Problem	9	9
Mechanics Altered	9	9
Incorrect Measurement	8	8
Device Slipped	7	7
Insufficient Information	7	9
Noise, Audible	6	6
Improper or Incorrect Procedure or Method	6	6
Retraction Problem	5	5
Material Separation	5	5
Appropriate Term/Code Not Available	5	5
Data Problem	5	5
Device Fell	3	3
Mechanical Jam	3	3
Fitting Problem	3	3
Calibration Problem	3	3
Defective Component	2	2
Loss of Power	2	2
Energy Output Problem	2	2
Entrapment of Device	2	2
Unintended Movement	2	2
Unexpected Shutdown	2	2
Intermittent Energy Output	1	1
Excessive Heating	1	1
Unintended Electrical Shock	1	1
Device Difficult to Maintain	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Unintended Ejection	1	1
Computer Software Problem	1	1
Failure to Cycle	1	1
Misconnection	1	1
Vibration	1	1
Component Missing	1	1
Device Displays Incorrect Message	1	1
Patient-Device Incompatibility	1	1
Connection Problem	1	1
Device Damaged by Another Device	1	1
Inappropriate or Unexpected Reset	1	1
Material Deformation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	512	515
Burn(s)	257	257
No Consequences Or Impact To Patient	169	169
Insufficient Information	82	82
Partial thickness (Second Degree) Burn	81	81
Burn, Thermal	79	79
Patient Problem/Medical Problem	66	66
Injury	62	62
Superficial (First Degree) Burn	43	43
No Known Impact Or Consequence To Patient	39	39
Foreign Body In Patient	15	15
No Information	12	12
Pain	9	9
Burning Sensation	4	4
Laceration(s)	3	3
Full thickness (Third Degree) Burn	3	3
Device Embedded In Tissue or Plaque	3	3
Blister	2	2
Skin Burning Sensation	2	2
Tooth Fracture	2	2
Needle Stick/Puncture	2	2
Skin Tears	2	2
Numbness	1	1
Electric Shock	1	1
Eye Injury	1	1
Perforation	1	1
Scar Tissue	1	1
Ulceration	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
No Code Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Young Dental Manufacturing I, LLC	II	Nov-09-2023