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	558	559
Overheating of Device	443	443
Mechanical Problem	123	123
Temperature Problem	84	84
Dent in Material	47	47
Output Problem	45	45
Therapeutic or Diagnostic Output Failure	43	43
Defective Device	35	35
Physical Resistance/Sticking	34	34
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
Insufficient Information	8	10
Improper or Incorrect Procedure or Method	7	7
Device Slipped	7	7
Noise, Audible	6	6
Appropriate Term/Code Not Available	5	5
Data Problem	5	5
Retraction Problem	5	5
Material Separation	5	5
Fitting Problem	3	3
Mechanical Jam	3	3
Calibration Problem	3	3
Device Fell	3	3
Loss of Power	2	2
Unexpected Shutdown	2	2
Entrapment of Device	2	2
Energy Output Problem	2	2
Unintended Movement	2	2
Defective Component	2	2
Unintended Collision	2	2
Device Displays Incorrect Message	1	1
Inappropriate or Unexpected Reset	1	1
Failure to Cycle	1	1
Connection Problem	1	1
Device Damaged by Another Device	1	1
Excessive Heating	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Computer Software Problem	1	1
Material Deformation	1	1
Misconnection	1	1
Unintended Electrical Shock	1	1
Intermittent Energy Output	1	1
Patient-Device Incompatibility	1	1
Unintended Ejection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	523	526
Burn(s)	265	265
No Consequences Or Impact To Patient	169	169
Partial thickness (Second Degree) Burn	85	85
Insufficient Information	82	82
Burn, Thermal	79	79
Patient Problem/Medical Problem	66	66
Injury	62	62
Superficial (First Degree) Burn	44	44
No Known Impact Or Consequence To Patient	39	39
Foreign Body In Patient	15	15
No Information	12	12
Pain	9	9
Tooth Fracture	4	4
Burning Sensation	4	4
Laceration(s)	4	4
Full thickness (Third Degree) Burn	3	3
Device Embedded In Tissue or Plaque	3	3
Blister	2	2
Needle Stick/Puncture	2	2
Skin Tears	2	2
Skin Burning Sensation	2	2
Electric Shock	1	1
No Code Available	1	1
Perforation	1	1
Numbness	1	1
Scar Tissue	1	1
Eye Injury	1	1
Ulceration	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1

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